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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.

  • ORA, CDER Align on Manufacturing

    Nov 3, 2017

    The U.S. FDA continues to restructure its field activities, moving away from a geographic focus to a structure based on program-aligned commodity areas. As part of this process, CDER and the Office of Regulatory Affairs (ORA) recently began implementing a concept of operations agreement that better aligns drug review programs with facility inspections. Both field and review staff will work together as part of a team-based approach that provides a holistic overview of all elements that create risk, from drug substance to drug product to manufacturing.

    The Agency hopes this alignment will help prevent manufacturing delays due to inspection issues.

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  • TGA Responds to Increase in Clearance Docs

    Nov 3, 2017

    Due to the increase in GMP clearance applications, Australia’s Therapeutic Goods Administration (TGA) is implementing new process improvements. TGA estimates that 60% of clearance applications do not include all the supported evidence necessary to demonstrate that a manufacturing site meets requirements for supplying product to the Australian market. For all applications submitted on or after Sept. 26, TGA will conduct an application assessment once all outstanding fees have been paid. If the assessment finds certain information is missing, the agency will provide a written outline of the deficiencies noted.

    Applications submitted before Sept. 26 will have a one-time opportunity for sponsors to submit outstanding supporting information prior to assessment. TGA is also currently working on a revised GMP clearance guidance document and new Web-based Clearance Application Assistance Tool.

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  • India: Stability Data Required

    Nov 3, 2017

    In August, India’s Central Drugs Standard Control Organisation (CDSCO) notified all regional drug controllers that they must better enforce requirements for Indian manufacturers to submit quality data for nonpatent and proprietary medicines. CDSCO requires this data at the time of submission. Data should show that drug product is stable under storage conditions.

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  • East African Community Looks to EMA

    Sep 15, 2017

    The East African Community (EAC), a regional intergovernmental organization of six partner states in East Africa (Burundi, Kenya, Rwanda, South Sudan, Uganda and Tanzania), is exploring if the EMA can serve as model for developing a similar regulatory framework in the East Africa region. Representatives from medical regulatory agencies within these states visited EMA in May to explore potential opportunities for harmonization within the region.

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  • EMA Prepares for UK Departure

    Sep 15, 2017

    EMA continues to make preparations ahead of the departure of the United Kingdom from the European Union. In light of these preparations, the Agency has temporarily suspended some of its activities, including the e-submission project, the development of a transparency roadmap, and their participation in the benchmarking of EU regulatory agencies.

    Additionally, the Agency’s headquarters will eventually locate from its present site in London. As of August 1, the EMA has received 19 offers from member states to host its new headquarters. A final decision will be made on Nov. 20.

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  • FDA Looks at PACs for Biologics

    Sep 15, 2017

    In early August, the U.S. FDA released the draft guidance, CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports. This draft guidance provides recommendations to holders of biologics license applications for specified products regarding the types of minor changes that need to be documented in an annual report. In particular, the document outlines CMC controls for post-approval changes the Agency considers to have minimal adverse impact on product. Under current regulations, such minor changes must be documented in an annual report.

    Comments are due Oct. 10.

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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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  • 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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  • 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.

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  • CFDA Releases GMP Inspection Data

    Jul 5, 2017

    In early June, the China FDA released its annual drug inspection report for 2016. The Agency conducted 431 total inspections, including GMP inspections. The report shows another year of growth in the number of inspections of overseas manufacturers ordered by CFDA; however, the Agency only performed a fraction of these planned visits.

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  • Toolkit to Support Supply Chain

    Jul 5, 2017

    Recently, the U.S. FDA led a collaboration effort with participating Asia Pacific Economic Cooperation (APEC) regions to create a Supply Chain Security Toolkit for Medical Products. This toolkit contains training materials to educate regulators and industries in the Asia-Pacific region on best practices for ensuring the security of medical products in the supply chain. Training materials cover GMP, GDP, track and trace systems, surveillance/monitoring, etc. To further establish best practices in the global supply chain, APEC plans to also develop Training Centers of Excellence for Regulatory Science which will be responsible for furthering training on the toolkit.

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  • Supply Chain Pilot Commenting Period Extended

    Jul 5, 2017

    The U.S. FDA has extended the commenting period relating to supply chain elements of the Drug Supply Chain Security Act (DSCSA). The Agency is requesting comments on product identifiers for product tracing, supply chain technical capabilities, and identification of system attributes needed under the DSCSA.

    Comments now close April 30, 2018.

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  • 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.

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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.

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  • FDA Establishes Oncology CoE

    Mar 10, 2017

    The US FDA has established the Oncology Center of Excellence (OCE) and appointed Richard Pazdur, MD, as its director. The OCE is part of the FDA’s larger effort to better address the needs of cancer patients through a coordinated clinical review of drugs, biologics, and devices across the Agency’s three medical product centers.

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  • China Publishes 5-Year Drug Plan

    Mar 10, 2017

    In late February, the China FDA published its five-year plan (2016–2020) on food and drug safety. The Agency intends to use the plan to set stricter standards for medical equipment and drug quality by enhancing supervision. The plan finalizes the quality consistency evaluation for 289 generic drugs, revises 3050 national drug standards and 500 medical equipment standards, and requires 100% rate of updates for periodic drug safety reports.

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  • 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.

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  • Final Combo Product Guidance Out

    Jan 27, 2017

    In early January, the FDA released its final guidance on cGMPs for combination products. The finalized guidance addresses concerns industry had expressed regarding FDA communications related to combination products. In addition, the guidance discusses the role of the lead center and other Agency divisions responsible for cGMP issues for these types of products.

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  • Owners Responsible for Quality

    Jan 27, 2017

    The FDA released a guidance for industry on Nov. 22 describing how contract manufacturing organizations can use quality agreements to delineate their manufacturing activities to ensure compliance with current GMPs. According to this document, companies outsourcing pharmaceutical operations are responsible for the quality of the final product, not the outsourcing firm.

    Comments on the guidance are due at any time.

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  • New System for U.S. Drug Imports

    Jan 27, 2017

    Effective Dec. 29, certain data on FDAregulated products imported into the United States must be submitted through the Agency’s Automated Commercial Environment (ACE) system. This more streamlined import process is expected to result in efficient use of Agency resources and more effective enforcement of FDA regulations. ACE replaces the older Automated Commercial System. The new system offers a single window for importers, eliminating the need to submit information more than once.

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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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  • 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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  • Japan Seeks Collaborative API Effort

    Jan 27, 2017

    Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced in December plans to join the U.S. FDA and EMA to improve the GMP inspection process for sites producing APIs through a collaborative effort. Under this agreement, PMDA will be able to share information related to GMP inspections. This information would include inspection plans and results. This is part of PMDA’s International Strategy.

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  • New Inspection Process in China

    Jan 27, 2017

    The China Food and Drug Administration has committed to adopting a “double random” approach to inspections to improve oversight. This approach involves random selection of both the inspector and the organization or process being inspected.

    (Link in Chinese)

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  • New Solvent Added to ICH Q3C(R6)

    Jan 27, 2017

    ICH Q3C (R6), Impurities: Guideline for Residual Solvents, has entered the implementation period. The most recent update revises the Permissible Daily Exposure for Methyl isobutyl ketone (MIBK) and adds Triethylamine (TEA) as a new solvent.

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  • President Signs 21st Century Cures Act

    Dec 13, 2016

    On Dec. 13, President Barack Obama signed the 21st Century Cures Act into law. This Act creates a new pathway for regenerative medicines, requires less use of data in bringing drugs and devices to market, and encourages adoption of continuous manufacturing through FDA-provided grants.

    The Act also provides additional funding for research on cancer and opioid addiction.

    Continue reading »
  • FDA Releases Revised Metrics Guidance

    Nov 29, 2016

    On Nov. 23, the U.S. FDA released its revised guidance on quality metrics. This version includes comprehensive definitions for metrics categories as well as reporting tiers for various types of organizations. In addition, the document establishes an initial period where reporting of metrics will be voluntary.

    Comments are due March 27.

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  • FDA Seeks to Change GLPs

    Oct 3, 2016

    In August, the U.S. FDA proposed amending its Good Laboratory Practice (GLP) regulations to require a complete quality system approach for nonclinical laboratory studies. This approach is called a GLP Quality System and features safety and toxicity studies used to support product submissions to FDA. The Agency also seeks to revise the definition of a “testing facility” in light of current practices, such as multisite studies. This proposed revision is intended to build quality into nonclinical laboratory studies and help ensure data integrity.

    Comments are due Nov. 22.

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  • Health Canada On Track for Drug Shortage Deadline

    Oct 3, 2016

    This summer, Health Canada announced it is on track to meet requirements for reporting drug shortages via a third-party reporting site by its spring 2017 deadline. After the new reporting site is launched, it will replace the current drug shortages website. Before the new site is up, however, Health Canada expects companies to continue posting information about drug shortages and product discontinuances on the drugshortages.ca website.

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  • New Pre-RFD Process for Combo Product Submissions

    Oct 3, 2016

    The FDA plans to change its internal procedures for responding to sponsors on preliminary product classification assessments from the Office of Combination Products (OCP). This new process, the Pre-Request for Designation (Pre-RFD) process, will require sponsors to provide a detailed product description. Once OCP receives this information, the Office will make an assessment regarding product classification and Center assignment. The Agency’s goal is to respond to sponsors 60 days following receipt of all the necessary information. A draft guidance on this process is forthcoming.

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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.

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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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  • Indian Regulator to Recruit More Inspectors

    Oct 3, 2016

    India’s Central Drug Standards Control Organization (CDSCO) recently announced plans to recruit more than 500 new drug inspectors in 2017 as part of a five-year plan to ensure the quality of drug product manufacturing within India and drug product manufactured for export. In addition, CDSCO hopes to train the recruiters effectively to ensure uniform GMP inspections.

    CDSCO recently finished recruiting 147 drug inspectors as part of a push to enhance cGMP inspections of manufacturing units.

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  • PIC/S Releases Data Integrity Guide for Inspectors

    Oct 3, 2016

    PIC/S has released a draft data integrity guidance. This draft guidance is being made available to facilitate the effective implementation of data integrity elements into the routine planning and practice of GMP/GDP inspections. The guidance also provides support for risk-based data integrity inspections.

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  • 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 Responds to Zika

    Aug 11, 2016

    In a blog post over the summer, the U.S. FDA announced its plans for minimizing the impact of the Zika virus by partnering with other U.S. government agencies, the private sector and the international regulatory community, including the WHO and ANVISA (the Brazilian Health Regulatory Agency) on vaccines and treatments. As of July, 120 FDA staff members are working in response to the outbreak.

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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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  • FDA Opens New Oncology CoE

    Aug 11, 2016

    U.S. FDA Commissioner Robert Califf, MD, selected Richard Pazdur, MD, to become acting director of the new Oncology Center of Excellence. This Center will be a place where regulatory scientists and reviewers with oncology clinical expertise in drugs, biologics and devices will collaborate and support an integrated approach to the advancement of cancer treatment.

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  • FDA Releases Additional Compounding Guidances

    Aug 11, 2016

    On July 7, the U.S. FDA issued two draft guidances regarding compounded drug products that are “essentially a copy” of approved and commercially available drug products. Comments on both draft guidances are due Oct. 11.

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  • FDA Releases Elemental Impurities Guidance

    Jul 27, 2016

    The U.S. FDA draft guidance, Elemental Impurities in Drug Products, provides recommendations regarding the control of elemental impurities of human drug products marketed in the U.S. in order to remain consistent with the implementation of ICH Q3D. The draft guidance will also assist manufacturers of compendial drug products in responding to the issuance of the USP requirement for the control of elemental impurities.

    Comments on the this guidance are due Aug. 30.

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  • New WHO Tech Report Offers Data Management Guidance

    Jul 27, 2016

    The World Health Organization has released Technical Report Series No. 996, which provides guidance on good data and record management practices based on feedback collected at an October 2014 meeting.

    [Editor's Note: Check out PDA's data integrity resource page for more information on this important topic!]

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  • 16 New Members Officially Join ICH

    Jul 27, 2016

    To advance its mission of becoming a global platform for harmonization for better health, ICH has welcomed two new members and 14 observers who represent regulatory authorities, regional health initiatives and pharmaceutical industry groups at its June meeting. These include:

    • Association of Southeast Asian Nations (ASEAN)
    • Biotechnology Innovation Organisation (BIO)
    • Central Drugs Standard Control Organization (CDSCO, India)
    • Council for International Organizations of Medical Sciences (CIOMS)
    • Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS, Mexico)
    • East African Community (EAC)
    • European Directorate for the Quality of Medicines & HealthCare (EDQM)
    • Health Sciences Authority (HSA, Singapore)
    • International Pharmaceutical Excipient Council (IPEC)
    • Ministry of Food and Drug Safety (MFDS, South Korea)
    • Roszdravnadzor (Russia)
    • Food and Drug Administration (TFDA, Chinese Taipei)
    • Therapeutic Goods Administration (TGA, Australia)
    • United States Pharmacopeia (USP)
    • International Generics and Biosimilars Association (IGBA)
    • World Self-Medication Industry (WSMI)
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  • CBER Releases 2015 Annual Summary

    Jul 7, 2016

    CBER recently published its Annual Summary for 2015. This summary contains an overview of the reports CBER received during the fiscal year, including detailed information regarding the number and types of deviation reports.

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  • New Quality Metrics Conformance Guide Available

    Jul 7, 2016

    The U.S. FDA recently released its Quality Metrics Technical Conformance Guide, Version 1.0, which serves as the technical reference for the draft FDA guidance, Request for Quality Metrics. The guide provides recommendations about submission of information that will support the FDA’s calculation of quality metrics.

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  • FDA Guidance Looks at ISO Standards for Device App Evaluations

    Jul 7, 2016

    To assist industry in preparing premarket applications, humanitarian device exceptions, investigational device applications and premarket notifications, the U.S. FDA has released its Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process' guidance.

    Comments may be submitted at any time.

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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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  • INTERPOL Operation Nets Fake Meds

    Jul 7, 2016

    An INTERPOL sting operation, which targeted the illegal online sale of medicines and medical devices, resulted in 393 global arrests and the seizure of more than 12.2 million fake and illicit medicines valued at more than $53 million.

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  • A Case for Quality for Devices

    Jul 7, 2016
    The U.S. FDA’s Case for Quality initiative encourages open engagement between all members of the device ecosystem to enhance the quality of medical devices. This program is one of the Center for Devices and Radiological Health’s 2016-2017 strategic priorities.
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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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  • FDA Seeks to Strengthen Protection of Reg Filing Data

    Jul 7, 2016
    The U.S. FDA is working on strengthening its protection of pharmaceutical data submitted in regulatory filings during the approval process of new drugs. According to the Agency’s 2015-2018 Information Technology Strategic Plan, the U.S. FDA will implement independent verification and validation for high‐risk systems, move to a next‐generation network security architecture and improve the agency's patch management plan.
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