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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

  • Counterfeit Enters German Drug Supply Chain

    Jul 5, 2017

    According to a June press release from the German Federal Institute for Drugs and Medical Devices, a batch of hepatitis C drug, Harvoni®, has entered the German drug supply chain. A patient notified authorities of a difference in the color of the product. Gilead Sciences, the manufacturer, recalled the batch; analysis showed that the product had been repackaging and relabeled.

    Counterfeit Harvoni® batches have also been discovered in Israel, Japan and Switzerland over the past 18 months. The Federal Institute for Drugs and Medical Devices is working with EMA and other regulatory agencies to determine if other European markets have been affected.

    Read more
  • MHRA Publishes Inspection Data

    Jul 5, 2017

    MHRA released its annual report covering inspection findings of facilities producing drug product for the UK market in May. This report covers 324 inspections in 2016, of which 34% were of overseas facilities. Top deficiencies noted in the report included issues with quality systems, sterility assurance concerns, production problems, complaints/recalls, and more. MHRA releases this data publicly so companies can use it as part of continuous improvement.

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  • EMA Addresses UK Exit

    Jul 5, 2017

    On May 2, EMA released a Q&A document in response to the United Kingdom’s withdrawal from the European Union. This document covers procedures for marketing authorization holders currently established in the United Kingdom, orphan designation procedures, role of Qualified Persons, etc. EMA expects to update this document in the future.

    In addition, a recent meeting of EMA’s Management Board covered how the Agency will handle the UK’s plans to exit the European Union. The Agency is working on the assumption that the UK will be considered a third country outside the EU and European Economic area as of March 30, 2019, and will continue to participate in all formal meetings and retain its speaking and voting rights.

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  • Concerns Shared About ATMP GMPs

    Apr 26, 2017

    PIC/S expressed concerns about the European Commission’s proposed advanced therapy medicinal products (ATMP) GMP guidelines in a letter dated Feb. 24. In particular, PIC/S is concerned the proposed guidelines will lead to a nonharmonized approach to ATMP GMPs in addition to lowering standards for ATMP GMPs.

    Read more
  • Paper Addresses Non-distillation WFI

    Apr 26, 2017

    In March, EMA released a concept paper outlining plans to revise the Agency’s guidance covering the quality of water used for pharmaceutical purposes. The revision takes into account the recent decision by the European Pharmacopoeia to accept non-distillation water technologies to produce water for injections (WFI).

    Comments are due June 6.

    Read more
  • FDA, EMA Agree on Mutual Reliance

    Mar 10, 2017

    In early March, both the US FDA and EMA announced that the European Union and United States have agreed to recognize each region’s GMP inspections of pharmaceutical manufacturing facilities. This agreement follows three years of work between both agencies on the Mutual Reliance Initiative. Mutual recognition of inspections is expected to result in avoidance of duplicate inspections, reduced inspection costs, and allows regulators to better allocate resources to other regions that present greater risks.

    The European Union is expected to have completed its assessment of FDA by Nov. 1, with FDA having completed its own assessment of eight EU member states.

    Read more
  • EMA Launches Biosimilar Pilot

    Jan 27, 2017

    EMA will launch a biosimilar-focused pilot project this month. The Agency plans to use this pilot to provide biosimilar developers with recommendations as to what studies they should be conducting based on data from the innovator product. This program is open to all companies looking for scientific advice on developing a biosimilar product.

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  • FDA Making Strides with MRI

    Jan 27, 2017

    The FDA recently announced that the Agency hopes to sign an agreement with the European Union soon on the Mutual Reliance Initiative (MRI). At this time, the two entities are completing assessments of drug manufacturing inspectorates for two to four EU countries. The Agency launched this initiative with the EU in 2014 to create an expanded inspectorate that enables FDA investigators and trusted EU partners to work together to avoid duplicate inspections by relying on each region’s inspection information. This would allow the United States and European Union to devote more resources to regions where drug manufacturing has greatly increased, such as China and India.

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  • MRHA Guidance Addresses Health Apps

    Oct 3, 2016

    The British regulatory authority MHRA released a guidance in August outlining when certain health apps can be considered medical devices. The guidance features an interactive step-by-step PDF to help developers determine if their product constitutes a medical device. In addition, the guidance offers recommendations for navigating the regulatory pathways for approval. The guidance was developed due to the proliferation of health-related apps available on the marketplace and to clear up confusion.

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  • EMA Releases WFI Q&A

    Oct 3, 2016

    EMA has provided a set of draft questions and answers on the production of water for injections by nondistillation methods, i.e., reverse osmosis, to provide preliminary guidance until the ongoing revision of Annex 1 of the GMP guide is complete.

    Industry comments on the document are due Nov. 4.

    Read more
  • EMA Reorganizes into Leaner Organization

    Aug 12, 2016

    Beginning Sept. 1, EMA will reduce the number of divisions dealing with human medicines from four to three, create a new function to strengthen collaboration between the Agency and national competent authorities, and streamline the division responsible for administration and corporate management. These changes are expected to result in leaner operations and better administrative support. This reorganization builds on the Agency’s 2013–2014 reorganization.

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  • FDA/EMA Discussions Include MRI

    Aug 11, 2016

    Over the summer, members of the U.S. FDA met with several European Union regulatory counterparts and stakeholders in Brussels to discuss ways to strengthen their shared commitment to product safety and public health. Discussions covered global supply chain issues, globalization of drug development, and the Mutual Reliance Initiative (MRI). Toward the conclusion of the trip, FDA officials reviewed EMA’s mutual reliance plans. Both agencies expressed hope to continue regulatory alignment.

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  • EMA Releases Annual Report for 2015

    Jul 7, 2016

    The European Medicines Agency’s (EMA) 2015 annual report, published May 17, 2016, focuses on the Agency’s core tasks, including evaluation of medicines, support of research and development of new and innovative treatments and the monitoring of benefits and risks of medicines in practice. The Annual Report also highlights some of the main projects, initiatives and achievements from 2015 that have had a significant impact on EMA and its operations.

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  • EMA Process Val Guideline Effective this Fall

    Jul 7, 2016
    EMA's guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission will go into effect Nov. 1, 2016.
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  • EMA Adopts 2020 Work Program

    Jul 7, 2016

    At its June meeting, the European Medicines Agency (EMA) Management Board adopted EMA’s multiannual work program to 2020 and its framework for stakeholder relations management. In addition, the Board approved an updated schedule for the implementation of the new EudraVigilance system.

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  • EMA Looks at Environmental Risks

    May 12, 2016

    EMA released concept paper on April 28 outlining how to assess the potential environmental risks of medicinal products. The paper includes considerations for risk mitigation strategies for reducing the impact of drug products on the environment.

    Comments are due Oct. 31.

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  • EU/Chinese Work Groups Meet on Anticounterfeiting

    May 5, 2016

    The European Union and China Working Group on Pharmaceuticals recently met to discuss drug evaluation and approval procedure reform, anticounterfeiting legislation and management of online pharmacies. This comes as part of the Consultation and Cooperation Mechanism agreement signed in 2013, which states the China Food and Drug Administration and the European Commission will meet more regularly for constructive dialogue on pharmaceutical laws and regulations.

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  • EMA Releases Sterilization Draft Guideline

    May 5, 2016

    EMA has released a draft guideline on the sterilization of medicinal products, active substances, excipients and primary containers. This draft guideline describes expected documentation for sterile products in the quality dossier for a marketing authorization application or a variation application for a medicinal product.

    Comments are due Oct. 13.

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  • EMA Elects New Chair for Management Board

    Apr 5, 2016

    On Mar. 17, Christa Wirthumer-Hoche was elected as chair of the European Medicines Agency’s Management Board for a three-year term. The Management Board sets the Agency’s budget, approves the annual work program and is responsible for ensuring that the Agency works effectively and cooperates successfully with partner organizations across the EU and beyond.

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  • EMA Launches PRIME

    Mar 31, 2016

    EMA recently launched PRIME—PRIority MEdicines—its new scheme to strengthen support for the development of medicines that target an unmet medical need. PRIME is based on enhanced interaction and early dialogue with developers of promising medicines to optimize development plans and speed up evaluations so that these medicines can reach patients earlier.

    Read more
  • EP to Accept Nondistilled WFI

    Mar 23, 2016

    The European Pharmacopoeia has revised its monograph on water for injection (WFI) to accept WFI that undergoes a purification process equivalent to distillation, such as reverse osmosis. This revision becomes effective April 2017.

    Read more
  • EMA Sets Up Zika Task Force

    Feb 24, 2016

    EMA has set up a task force to look into the recent Zika outbreak. As part of the Agency's efforts to combat the outbreak, EMA wants input from drug developers working on products that may prove promising in stopping the spread of the disease.

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  • Anticounterfeiting Tech Now Required in EU

    Feb 15, 2016

    New EU regulations now require new safety features to prevent counterfeiting: a unique barcode and an anti-tampering device for drug products.

    Read more
  • EMA Publishes 2016 Workplan for GMP/GDP IWG

    Feb 5, 2016

    EMA has published its workplan for 2016 for the GMP/GDP Inspectors Working Group. Topics to be discussed during meetings of the working group throughout 2016 include Mutual Recognition Agreements (MRAs), the Joint Audit Programme, data integrity, GMPs for active biological substances, and more.

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  • EMA Recommends 93 New Medicines in 2015

    Jan 20, 2016
    In 2015, EMA recommended 93 medicines for approval, including 39 new active substances.
    Read more
  • Q&A Document Addresses QP Template

    Jan 13, 2016

    In December, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) published a Q&A document summarizing the most common questions asked by stakeholders regarding EMA’s Qualified Person (QP) declaration template and associated guidance document. The Q&A document addresses the QP's role in evaluating the final active substance manufacturer versus factoring in the sites for all raw materials within the supply chain as well as the role of audits from national regulatory bodies.

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  • EMA Adopts 4-Year Network Strategy

    Jan 7, 2016

    On Dec. 18, EMA announced that its Management Board and Heads of Medicines Agencies have adopted a network strategy for the next four years. This strategy outlines common challenges and opportunities across the EMA network that pertain to regulating public health, setting out a roadmap for addressing these priorities by 2020. It also builds on EMA’s roadmap to 2015 and the HMA strategy for 2011–2015, and will result in multiannual implementation plans for EMA and related bodies.

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  • EC Receives Proposal to Label EU-Sourced Drug Components

    Dec 3, 2015

    The European Commission has received a proposal from the French government for the use of a pictogram label for medicinal products that would indicate that the product or its excipients was sourced in the European Union.The proposed pictogram would be a rectangle divided into four sections corresponding to four categories: active ingredients, excipients, production and packaging. For any category produced in the European Union, the word “Europe” would appear in white letters on a blue background. For those manufactured outside the European Union, a black cross would appear.

    This comes in response to concerns about GMP quality for products manufactured outside the European Union.

    The proposed pictogram is currently up for review by the Commission.

    Read more
  • MHRA Signs MoH with Indian Counterpart

    Nov 19, 2015

    On Oct. 5, the United Kingdom’s Medicines and Healthcare products regulatory agency, MHRA, recently signed a Memorandum of Understanding with India’s Central Drug Standard Control Organization (CDSCO) as part of an agreement to increase collaboration between the two countries on public safety.

    This is the first Memorandum of Understanding signed with CDSCO. Both agencies hope this agreement facilitates expanded exchange of information and opportunities for collaboration.

    Read more
  • NEW EMA Executive Director Takes Office

    Nov 18, 2015

    Guido Rasi officially assumed his duties as Executive Director of EMA this week. He was appointed on Oct. 13 for this five-year role. In December, he will outline his plans for the next five years.

    Read more
  • Annex 16 Revised to Reflect Globalized Supply Chains

    Nov 13, 2015

    In October, the European Commission released the revision to Annex 16: Certification by a Qualified Person and Batch Release. This revision takes into account the globalization of supply chains and new quality control strategy. In addition, it takes into account the ICH Q8-Q10 documents.

    The revised Annex 16 comes into effect April 15, 2016.

    Read more
  • EMA Seeks to Facilitate Accelerated Assessment of Critical Medicines

    Nov 11, 2015

    The European Medicines Agency released a reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines. This is in response to a recognized need to foster development of medicines that address unmet medical needs. Earlier efforts to address this need have included the Adaptive Pathways pilot and revisions to the guidance on accelerated assessment.

    Comments are due by Dec. 23.

    Read more
  • Annex 16 Revised due to Globalized Supply Chain

    Oct 16, 2015

    Earlier this week, the European Commission released  Annex 16: Certification by a Qualified Person and Batch Release. Annex 16 was revised on account of the greater globalization of pharmaceutical supply chains and the Falsified Medicines Directive. In addition, this revision also looks at implementation of ICH Q8, Q9, and Q10.

    This revision becomes effective April 15, 2016.
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  • Guido Rasi Nominated as EMA Executive Director

    Oct 6, 2015

    EMA has nominated Guido Rasi as the Executive Director of the Agency at an Oct. 1 session of EMA’s Management Board. He is expected to appointed following a statement to the European Parliament on Oct. 13.

    Andreas Pott, Deputy Executive Director, will continue to head EMA’s operations until Rasi officially assumes responsibilities as Executive Director.

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  • Real Time Release Draft Up for Comment

    Oct 6, 2015

    The European Commission released the comprehensive draft paper, Annex 17: Real Time Release Testing. This paper revises the 2002 version and incorporates the application of real-time release testing to any stage of the manufacturing process. Since 2002, the adoption of ICH Q8–Q11 has led to changes in the manufacturing environment, requiring an updated version of the document.

    Comments are due Dec. 11.

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  • Europe Moves Toward GMPs for IMPs

    Sep 3, 2015

    In late August, the European Commission released three documents for public consultation on GMPs for investigational medical products (IMPs). One document is a consultation paper that outlines the Commission’s views on GMPs for IMPs and the second document covers detailed guidelines in this area. And the third details implementation of the proposed GMPs.

    Comments are due Nov. 24.

    Read more
  • Israel and Brazil Added to List of API Manufacturers

    Jul 20, 2015

    The European Commission in early July added Israel and Brazil to its list of countries with API manufacturing standards equivalent to those of the European Union. This means that API manufacturers in Israel and Brazil will not need written confirmation from European regulators that their GMPs are equal to European GMPs.

    Currently, the United States, Switzerland, Japan and Australia are already on the list. Other countries seeking to be added to the list include New Zealand, South Korea, Taiwan, India and China.

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  • U.S., European Regulators Collaborate on Inspections, Data Integrity

    Jul 20, 2015

    The U.S. FDA, the EMA and the European Commission plan to mutually align with regard to inspections of drug manufacturing sites in addition to stressing the importance of data integrity. Representatives from these three agencies met to discuss cooperative activities for the next two years at a recent meeting at the FDA headquarters in Silver Spring, Md.

    This meeting was part of a regular series of bilateral meetings between senior European and U.S. regulators. Other topics of interest at the meeting covered included cluster reviews for bilateral pharmacovigilance, biosimilars, pediatric and veterinary medicines.

    Read more
  • EMA Releases Finished Dosage Forms Guideline for Comment

    Jul 13, 2015

    In mid-July, EMA released its guideline covering manufacturing of finished dosage forms. This guideline details information that must be included in CTD Module 3 of the marketing authorization application. In addition, the guideline looks at current practices as they relate to global supply chains and manufacturing and takes the ICH Q8 guideline on pharmaceutical development into account.

    Comments are due Jan. 9, 2016.

    Read more
  • New Proposed EU Guidelines for Drug Importers

    Jun 3, 2015

    At the end of May, EMA released concept paper offering new guidelines for importers of medicinal products in the EU for public comment. This paper was developed in response to the growing numbers of drug products manufactured outside of the EU. The drug supply chain has increased in complexity; most GMP noncompliance statements loaded into the EudraGMDP database concern thirty party manufacturers.

    Comments are due August 29.

    Read more
  • EC Publishes Annex 15 Responses

    Jun 2, 2015

    On May 11, the European Commission has the responses from public stakeholders on the Annex 15: Qualification and Validation revision.

    Read more
  • EP Looks at Reverse Osmosis for WFI Monograph

    Apr 29, 2015

    The European Pharmacopoeia posted a proposed draft of a revision to its Water for Injections (WFI) monograph on April 1. This revision takes into account nondistillation methods for producing injection-quality water, namely reverse osmosis combined with deionization and ultrafiltration.

    Comments on the proposed revision are due June 30.

    Read more
  • Annex 15, "Qualification and Validation," Now Updated

    Apr 8, 2015

    Annex 15, “Qualification and Validation,” of the EU GMP Guide has been updated. The new version will harmonize with the principles of ICH Q8–Q10 as well as the EMA guidance on process validation. These updates include the following: retrospective validation no longer considered acceptable, new points on data integrity, “ongoing process verification” now must be based on equivalent documentation, and more.

    The updated version of Annex 15 becomes effective Oct. 1.

    Read more
  • Excipient Guidelines to Become Stricter in 2016

    Apr 6, 2015

    The European Commission announced on March 21, an updated and more detailed version of its Guidelines on Risk Assessment of Excipients. Under these new guidelines, manufacturing authorization holders are required to implement risk assessments of their entire supply chains from raw material sources to packaging.

    The steps taken for maintaining quality of an excipient must be extensively documented with a track-and-trace system fully in place. A quality control expert is now required to assess the excipients and release batches.

    These guidelines become effective March 21, 2016.
    Read more
  • European Commission Updates API GDP Guidelines

    Apr 6, 2015

    On March 21, the European Commission announced changes to its Guidelines on GDP for APIs, aimed at API importers and distributors. These changes include: requirements for API distributors to implement a quality system featuring a designated person with risk management responsibility at each point in the distribution chain, a traceable supply chain, suitable cold chain conditions, documented and investigated deviations to established procedures, effective CAPAs in place, one-year record retention policies, and examinations of all API deliveries for damage.

    The new guidelines become effective Sept. 21.
    Read more
  • EMA Network Develops 2020 Strategy

    Mar 31, 2015

    EMA released a consultation paper March 31 outlining a draft network strategy for European Medicines Agencies Network. EMA along with various health authority leaders developed this strategy to focus on expanding collaboration across the European Union on health matters. The strategy’s four themes are: human health, animal health, optimization of the network’s operations, and the global regulatory environment.

    Comments from stakeholders are due June 30.

    Read more
  • EMA to Revise Some Documentation Requirements for Clinical Trial Materials

    Mar 31, 2015

    Comments due June 30 on EMA’s concept paper on the need to revise requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials.

    Read more
  • EMA Management Board Elects New Vice Chair

    Mar 24, 2015
    The EMA’s Management Board has elected Christa Wirthumer-Hoche as its Vice-Chair. She replaces Walter Schwerdtfeger.

    Wirthumer-Hoche is currently Head of the Austrian Medicines and Medical Devices Agency.
    Read more
  • New Vice Chair for MHRA Commission Named

    Mar 11, 2015

    Angela Thomas is now the vice chair of MHRA’s Commission on Human Medicines. She replaces Ian Weller.

    Read more
  • EMA Releases Annex 1 Revision Concept Paper for Comment

    Feb 6, 2015

    EMA’s concept paper covering the revision of Annex 1’s GMP guidelines for manufacturing sterile product has been released for comment. This follows agreement on the document in January between EMA’s GMP/GDP Inspectors Working Group and PIC/S.

    Comments are due March 31.
    Read more
  • EMA GMP Guide Revisions Account for Cross-Contamination and Toxicological Assessments

    Feb 5, 2015

    Chapters 3 and 5 of the GMP Guide covering premises and equipment and production respectively have been updated to account for improvements to the guidance on cross-contamination and references to toxicological assessment.

    These updates become effective March 1 in an effort to align with the EMA guideline Setting Health Based Exposure limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities.

    Read more
  • Britain’s MHRA Releases Data Integrity Guidance

    Jan 27, 2015

    On Jan. 23, Britain’s MHRA released a guidance outlining the authority’s expectations for data integrity within the industry. The document also lists MHRA’s definitions for data integrity-related terms.

    The guidance is intended complement existing EU GMP regulations.
    Read more
  • EMA Seeks Expanded Global Generics Access

    Jan 22, 2015
    As part of the International Generic Drug Regulators Pilot (IGDRP), EMA will share its assessments of generic medicine applications with collaborating regulatory authorities outside the European Union as part of an effort to facilitate efficient access to affordable generics across the globe.
    Read more
  • EMA Approves First Stem Cell Therapy Product in Europe

    Jan 6, 2015

    EMA approved Holoclar in December for use in the European Union. This is the first advanced therapy medicinal product (ATMP) using stem cells that has been approved in Europe. Holoclar treats limbal stem cell deficiency, a rare eye condition that can cause blindness.

    Read more
  • New European Regulation Covers API GMPs

    Dec 17, 2014

    In November, the European Commission published a new regulation covering GMPs for APIs. This regulation outlines principles and guidelines for active substance GMPs. This includes exported active substances.

    The regulation became effective Dec. 15.

    Read more
  • Guideline Takes Risk-based Approach to Contamination in Shared Facilities

    Dec 11, 2014

    EMA recently published the final version of its Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. This document takes a risk-based approach to the management of contaminants in shared facilities.

    The guideline comes into effect June 1.
    Read more
  • EMA and FDA Confer in London on Mutual GMP Inspections

    Dec 1, 2014

    Representatives from the U.S. FDA met with a cross-agency team comprised of members from EMA, the European Commission and GMP experts from various EU member states in London Nov. 14 and 17 to discuss progress on mutual reliance between FDA and the European Union on GMP inspections.

    Although there has been an ongoing initiative around GMP inspections and mutual recognition for many years, due to increased momentum, this meeting is supposed to be the first face-to-face meeting of both teams.

    Read more
  • MHRA Releases Revised GMP Deficiencies Report

    Nov 18, 2014

    Britain’s MHRA recently published its inspection trend data from January 2013 to December 2013 in a revised format. The report also includes information about long-term trends in the “top 10 deficiencies” categories.

    Representatives from PDA were also involved in the revision of this report; see page 43 of the November/December 2014 PDA Letter.

    Read more
  • EMA Releases Guideline on New Flu Vaccine Framework

    Oct 30, 2014

    EMA has released the third module of a new overarching guideline on influenza vaccines. This guideline proposes establishment of a revised regulatory framework to facilitate more efficient assessment of new flu vaccines. It applies only to vaccines which have received ample regulatory experience as well as some new forms.

    Comments are due January 30.
    Read more
  • EMA Guideline Seeks to Avoid Repetition in Biosimilar Development

    Oct 30, 2014

    EMA has adopted a new guideline on biosimilars. This guideline allows for the possibility for companies to use a comparator authorized outline the European Economic area during clinical investigation. This is expected to facilitate global development of biosimilars as well as avoid repetition in clinical trials.

    The guideline becomes effective April 30.
    Read more
  • EMA to Release Clinical Reports to General Public

    Oct 8, 2014

    On Oct 2, EMA’s Management Board adopted a new policy to publish clinical reports contained in all applications for centralized marketing authorizations. The Agency hopes this new policy will better allow the general public to understand its decisionmaking as well as avoid duplication of clinical trials, foster innovation and encourage development of new products. Information that may be considered commercially confidential will be redacted.

    The policy will be effective January 1, 2015 and will apply to all authorizations submitted after that date.

    Read more
  • EDQM: Undeclared APIs Now a Major Problem In Europe

    Oct 2, 2014
    Sept. 10–11, the European Directorate for the Quality of Medicines & Healthcare (EDQM) held its second symposium on strategies to combat counterfeit and other illegal medicinal products. The symposium consisted of representatives from forensic and customs laboratories, national food and drug regulatory agencies, enforcement groups and the European Commission. According to participants, undeclared APIs and other active substances in products offered for sale remain a pressing issue within Europe. These products are often purchased from the legal market as well as acquired from uncontrolled sources.
    Read more
  • EMA Addresses Adaptive Licensing Pilot Questions

    Sep 19, 2014
    On Sept. 10 the EMA released a document featuring frequently asked questions from companies regarding the Agency’s adaptive licensing pilot project. The document also clarifies terms of engagement and possible outputs for applicants.
    Read more
  • Chapters in EU GMP Guide Now Finalized

    Sep 4, 2014
    The European Commission has published the final version of the Chapters 3, 5, and 8 of the EU GMP Guide. Chapter 3 covers premises and equipment, Chapter 5 covers production, and Chapter 8 covers complaints, quality defects and product recalls.

    These chapters will be effective March 1, 2015.
    Read more
  • Revision to Part II of GMP Guide on Active Substances as Starting Materials

    Sep 4, 2014
    Effective Sept. 1, the European Commission has published a revised version of Part II of the EU GMP Guide – Basic Requirements for Active Substances used as Starting Materials. This revision is due to changes in various Annexes of the Guide.
    Read more
  • Europe Seeks to Expand International Collaboration on Generics

    Aug 20, 2014

    The European Union is currently leading the International Generic Drug Regulators Pilot (IGDRP) to share, upon request from generic pharma companies, the assessment reports generated as part of the decentralized procedure with collaborating regulatory authorities outside the European Union. The initial phase of the project will involve collaborating with Australia, Canada, Taiwan and Switzerland.

    The European Union hopes to use this pilot to expand information-sharing so that medicines can be authorized in different countries at approximately the same time.

    Read more
  • API Committee Releases Two New Publications

    Jul 2, 2014
    The Active Pharmaceutical Ingredients Committee (APIC), part of the European Chemical Industry Council, recently released two documents. One, “How to document,” offers instruction on implementing EU draft guidelines from February 2013 on GDPs for APIs and the WHO guideline on GTDP for starting materials. The other publication provides information on how companies can formulate cleaning validation programs.
    Read more
  • Comments Due Oct. 31 for EMA's ATMP Guidance

    Jun 30, 2014
    The EMA has released a guidance on how advanced therapies should be classified, particularly which products can be classified as ATMPs and which cannot. Comments are due Oct. 31.
    Read more
  • MHRA Committee Explores Supply Chain Issues and More

    Jun 26, 2014
    Britian’s MHRA has published meeting minutes for the GMP/GDP Consultative Committee meeting that occurred April 11 in London. Discussion topics included GDP deficiency data, the Compliance Management Project, the new process licensing portal, self-inspection and data integrity, and more.
    Read more
  • EMA Publishes Process Validation Revision

    Mar 19, 2014

    In late February, the EMA published its revised process validation guideline. This revision emphasizes continuous process verification and incorporates modern GMP aspects into the guideline, including integration of ICH Q8–Q10, process analytical technology (PAT), QbD, real-time release testing, inclusion of the Annexes and harmonization with the U.S. FDA’s process validation guidance. This revised guideline will then come into effect in August.

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  • EMA Launches Drug Shortages Catalog

    Nov 6, 2013

    As part of a short-term action to address drug shortages in the European Union, EMA launched a public catalog of drug shortages on its website. The Agency announced that any drug that’s in shortage in more than one member state would be listed. The catalog would be similar to the U.S. FDA’s list of drug shortages on its website. The EMA catalog is part of the Agency’s 13-point plan to address drug shortages.

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  • EMA Official to Retire After 16 Years

    Jul 31, 2013

    The EMA has announced the retirement of Patrick Le Courtois, Head of Human Medicines Development and Evaluation. Le Courtois first joined EMA in 1997 and had been part of EMA’s senior management team since 2001. He had been in his current position since 2009.

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  • EMA Releases Reorganization Details

    May 3, 2013

    EMA announced in early May initial details regarding the Agency’s planned reorganization. These changes are focused on increasing the efficiency of the organization’s committees. Additionally, EMA expanded access to its centralized databases to partners and stakeholders, making the Agency an informational hub.

    Changes start to go into effect at the beginning of August 2013. The full reorganization is expected to take approximately 18 months.

    Read more
  • EMA Biosimilars Draft Now Available

    May 2, 2013

    On May 2, EMA released the Agency’s draft guidance on biosimilars. This draft establishes principles for establishing whether or not a product can be classified as a biosimilar. Additionally, the document lists principles that must be applied to biosimilars as well as outlining the choice of reference product.

    Comments should be submitted by Oct. 31.

    Read more
  • EMA to Begin PSUR Assessment

    Mar 27, 2013

    Beginning April 1, the EMA will conduct single assessments of periodic safety update reports (PSURs) of active substances used in both centrally and nationally authorized medicine products. Until recently, EMA had only assessed PSURs for centrally-authorized products. This new assessment will require the Agency to analyze all reports for medicines containing certain active substances, including for medicines authorized in more than one member state.

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  • European Commission Publishes GMP-Related Draft Guidelines

    Feb 6, 2013

    In early February, the European Commission published two GMP-related guidelines: Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human Use and Guidelines On The Principles Of Good Distribution Practices For Active Substances For Medicinal Products For Human Use. The first guideline requires companies to use quality risk management principles within ICH Q9 to assess and clarify risks presented by excipients while the second requires distributors of active substances to develop and maintain a quality system that lays out responsibilities, processes, and risk management procedures.

    Comments on both draft guidelines are due April 30.

    Read more
  • EMA Releases Draft Guidances on Cross- Contamination in Shared Facilities

    Jan 30, 2013

    The EMA recently released a draft guideline on setting exposure limits to use as risk identification for drug manufacturing in shared facilities, approved by the Safety Working Party in December. This draft guidance seeks to set scientifically-based threshold values for individual active substances applied as risk identification. The manufacturing of different pharmaceutical products in shared facilities provides the potential for cross-contamination due to active substance residues remaining on production equipment or other contact surfaces after cleaning. Active substances need to be restricted to a certain level considered safe. The development of a threshold value (a level of permitted daily exposure, or PDE) is key to this risk identification process.

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  • EMA Publishes Guidance on Summaries of Product Characteristics

    Jan 21, 2013

    In late January, EMA published a guidance for pharmaceutical companies detailing how to prepare and review summaries of product characteristics (SmPCs), consisting of presentations listing the information required in each section of the SmPC along with background information. Prepared by EMA's SmPC Advisory Group, the guidance also outlines the European Commission's guideline on SmPCs. The information within SmPCs is a core feature of marketing authorizations for all medicine products in the European Union and is also the basis for preparing package leaflets.

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