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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.

  • FDA Program Addresses New Tech

    Jan 4, 2016

    On Dec. 23, the U.S. FDA released a draft guidance about a new program for companies interesting in submitting CMC information on emerging manufacturing technologies. This information would be submitted as part of an IND, NDA, ANDA or BLA.

    Comments are due Feb. 22.

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  • CBER Releases 2015 Highlights

    Dec 22, 2015

    CBER has released its fiscal year report for 2015. Among the highlights:

    • Licensing of the first vaccine in the United States for prevention of meningitis disease caused by Neisseria meningitidis serogroup B
    • Extensive involvement in the containing the Ebola virus outbreak and working with industry groups on strategies for a vaccine
    • More than 70% of CBER's 2015 program alignment objectives were implemented on time

    In addition, CBER Director Karen Midthun, MD, has retired from her position and the FDA is actively seeking a replacement for her role.

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  • PIC/S Elects New Chairman

    Dec 22, 2015
    At its October meeting in Indonesia, PIC/S elected Paul Hargreaves of the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) as Chairman for 2016–2017. New office holders were also elected for seven PIC/S subcommittees
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  • USP Plans Revisions to Water Chapter

    Dec 7, 2015

    USP Chapter <1231> Water for Pharmaceutical Purposes is now under revision. Changes include organizing the chapter into nine specific sections, removal of language redundant to referenced wording in monographs and the addition of a detailed table of contents which will be hyperlinked in future online USP versions.

    Those interested in commenting on the revision can register with the Pharmacopeial Forum for free.

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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.

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  • USP Responds to FDA Biologics Naming Guidance

    Nov 30, 2015

    The United States Pharmacopeial Convention (USP) submitted comments on the U.S. FDA’s Nonproprietary Naming of Biological Products draft guidance, which proposes that all biologic products bear a nonproprietary name designated by the Agency. The USP comments were made in support of a uniform and scientifically based approach to naming that does not create unintended risks for patients and practitioners.

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  • FDA Provides Update on Cost of Quality for Devices

    Nov 24, 2015

    The U.S. FDA continues to look at Cost of Quality for device manufacturing. The Cost of Quality consists of a focus on quality, stakeholder engagement and data transparency. At this time, the Agency continues to explore development of tools to assess and quantify quality in device manufacturing.

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  • FDA Releases Finalized Guidance on Formal Meetings with Biosimilar Sponsors

    Nov 24, 2015

    The U.S. FDA recently released its finalized guidance on formal meetings between the Agency and sponsors of biosimilar products that provides recommendations to industry on formal meetings between the Agency and sponsors concerning the development and review of biosimilar products regulated by CDER and CBER.

    This finalizes the April 1, 2013 draft guidance.

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  • FDA Orange Book Now Available as a Mobile App

    Nov 23, 2015

    The U.S. FDA has released a mobile version of its Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the "Orange Book") as a PDF document and an app for both Apple and Android products. The app can be purchased through the Apple and Google app stores.

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  • Guatemalan Medicines Control Lab Retains ISO Accreditation

    Nov 23, 2015

    Guatemala’s official medicines control laboratory has retained its ISO 17025 accreditation, certifying its expanded ability to operate and reliably test the quality of its medicines to world-class standards.

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  • FDA Releases Revised Compounding Guidance

    Nov 20, 2015

    The revised U.S. FDA Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act Guidance describes some of the possible enforcement actions FDA can bring against individuals or firms that compound drugs in violation of the FD&C Act.

    This document was released in October.

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  • 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.

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  • 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.

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  • Rutgers University Receives FDA Grant to Support Continuous Manufacturing in Pharma

    Nov 18, 2015

    The U.S. FDA recently awarded a $4.9 million grant to support research and development of continuous manufacturing techniques for the pharmaceutical industry at the Engineering Research Center for Structured Organic Particulate Systems, a research consortium led by Rutgers University School of Engineering.

    This grant will be administered by NIH over a three-year period and will increase research and development efforts at the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) over the next 3 years.

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  • USP Releases Revised Compounding Chapter

    Nov 16, 2015

    In late September, USP released its proposed revision to General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. This revised chapter has been under review since 2010.Changes include collapsing the microbial risk categories of low, medium and high-risk into two categories (Category 1 and 2).

    Comments are due Jan. 31.

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  • 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.

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  • ICH Seeks Reform of Organization

    Nov 12, 2015

    In late October, ICH held its first Assembly and Management Committee meetings. These meetings are part of an overall reform of the organization that seeks to expand ICH into a worldwide initiative that goes beyond current ICH members. In addition, ICH seeks to include a wider selection of representatives from global industry sectors impacted by ICH harmonization.

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  • China FDA Releases Device GMPs

    Nov 12, 2015

    The China FDA recently released four guidelines promoting GMPs for medical devices. These guidelines strengthen regulatory oversight of medical device manufacturing in the country and cover onsite inspections of sterile medical devices, implantable devices and in vitro diagnosis reagents.

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  • 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.

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  • FDA Releases Draft on ICH M4E(R2)

    Oct 16, 2015

    FDA recently released a draft guidance on the ICH revision to its technical requirements for registering pharmaceuticals for human use, also known as M4E(R2). This revision standardizes how benefit-risk information is included in regulatory submissions. FDA hopes the revision facilitates greater communication between regulators and the industry.

    Comments are due Dec. 1.

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  • 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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  • New PIC/S GMP Guide Now Available

    Oct 15, 2015

    The revised PIC/S GMP Guide became effective Oct. 1. This revision incorporates the EU’s Annex 15 revision covering qualification and validation. 

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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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  • New Zealand Seeks Updated Drug, Device Regs

    Oct 6, 2015

    In mid-September, New Zealand announced plans to introduce a new bill in 2016 that would align the country’s medical device and drug product regulations with global standards. In addition, the new regulation would cover cell and tissue therapies, which are currently not regulated in the country. Regulators hope the new regulation will be flexible enough to ensure effective oversight while also being efficient in light of technological advances in therapeutic products.

    This development follows the end of efforts to create a joint regulatory body between New Zealand and Australia.

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  • FDA Finalizes ICH Q3D Guideline

    Oct 2, 2015

    ICH finalized its Q3D guideline that covers elemental impurities in January. Global regulators identified elemental impurities as an area in need of international harmonization and consensus. This guideline limits metal impurities in drug products and ingredients.

    In September, FDA released its final guidance on ICH Q3D. The guidance establishes permitted daily exposures (PDE) for 24 elements according to toxicity data. In addition, the guidance allows for a risk-based approach to assessing the possibility that elemental impurities with allowed PDE will be present in a drug product.

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  • FDA Finalizes Rule for Administrative Destruction of Drugs Refused Entry

    Sep 25, 2015

    Effective Oct. 15, FDA now has the authority to destroy any drug valued at $2,500 or less if it has been refused entry into the United States per provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA). This final rule gives the owner of the drug in question the opportunity to receive written notice about the Agency’s intent to destroy the drug and to provide testimony to FDA prior to destruction.

    FDA hopes this serves as a disincentive for importing adulterated, misbranded or unapproved drugs into the country.

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  • U.S FDA Releases Preliminary Report on Biosimilar Application Workload

    Sep 24, 2015

    On Sept. 24, the U.S. FDA released an interim report that contains preliminary data regarding workload and the full costs associated with reviewing biosimilar applications. According to this data, the labor costs associated with biosimilar reviews at the Agency stood at over $742 million in 2014 compared to $680 million in 2013—a 9% increase.

    Comments are due Oct. 26.

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  • New FDA Commissioner Nominated

    Sep 16, 2015

    The White House announced on Sept. 15 the nomination of Dr. Robert Califf for the post of Commissioner of the U.S. FDA. Since January, he has been serving as the Deputy Commissioner for Medical Products and Tobacco at the Agency. Prior to joining FDA, he served as Vice Chancellor of Duke University's School of Medicine and was also a professor of cardiology and medicine at the same school.

    He will replace Dr. Margaret Hamburg, who stepped down in March. Dr. Stephen Ostroff has been serving as Acting Commissioner following her departure.

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  • Solvent Upgraded Due to Health Concerns

    Sep 3, 2015

    The ICH Expert Working Group behind the Q3C Guideline recently revised the Permitted Daily Exposure (PDE) for Methyl isobutyl ketone (MIBK). This was listed in Q3C as a Class 3 solvent. Based on new data suggesting MIBK causes carcinogenic health problems in rodents, the Expert Working Group recommends upgrading MIBK to a Class 2 solvent.

    Comments are due Dec. 31.

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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.

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  • Naming Conventions for Biologics, Biosimilars Under Consideration

    Sep 1, 2015

    The U.S. FDA has released a guidance regarding naming of biologics and biosimilars. Under the Public Health Service Act, biologics must bear a nonproprietary name with an FDA-designated suffice. The Agency believes that shared nonproprietary names are not appropriate for all biologics. To ensure clear identification of biologics for the purposes of pharmacovigilance and to differentiate biologics that are not interchangeable, the Agency proposes that the suffix for biologics comprises four lowercase letters based on the nonproprietary name of the product.

    As far as interchangeable products, i.e., biosimilars, the Agency is still considering whether the suffix should be unique or share the same suffix as the reference product.

    Comments are due Oct. 27.

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  • FDA Guidances Now Easier to Search

    Sep 1, 2015

    The U.S. FDA’s new search tool enables those using the FDA website to search the Agency’s growing list of over 3,000 guidance documents quickly and efficiently. This search feature covers the entire FDA space—devices, drugs, biologics, etc. And the information is available in one centralized location for easy searching. Content is also tagged with metadata as well based on identified search terms.

    The search tool can be accessed at www.fda.gov/RegulatoryInformation/Guidances/.

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  • FDA Releases Quality Metrics Guidance

    Aug 20, 2015

    In late July, the U.S. FDA released the draft guidance, Request for Quality Metrics. This document outlines a set of measurements the Agency will use to evaluate the quality of facilities and manufacturing processes. These measurements are: lot acceptance rate, product quality complaint rate, invalidated out-of-specification (OOS) rate and annual product review (APR) or product quality review (PQR) on time rate. Manufacturers will need to submit data to FDA covering the number of attempted lots, lots pending disposition for more than 30 days, lots released, OOS results, etc.

    Comments are due Sept. 25.

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  • FDA Updates AMV Guidance

    Aug 20, 2015

    On July 27, the U.S. FDA released an updated version of the Analytical Procedures and Methods Validation for Drugs and Biologics guidance. This guidance replaces the draft guidance of the same name published in Feb. 2014 and explains how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity and potency of drug substances and drug products.

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  • ICH M7 Addendum Available for Comment

    Jul 23, 2015

    Following completion of Step 2b of the ICH process, the Addendum for ICH M7 Guideline Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk is now available for comment. This addendum complements the current harmonized M7 guideline and summarizes known mutagenic impurities regularly found during synthesis.

    The deadline for comments is January 31, 2016.

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  • 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.

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  • 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.

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  • 21st Century Cures Act Heads to U.S. Senate

    Jul 13, 2015
    On July 10, the U.S. House of Representatives approved the 21st Century Cures Act. The proposed law now heads to the Senate for a vote
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  • Malaysian MDA Extends Fast-Track Device Registration Period

    Jul 8, 2015
    Malaysia’s Medical Device Authority (MDA) has extended the deadline for temporary fast-track device registrations to June 30, 2016.
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  • Q&A for ICH Q7 Now Available

    Jul 8, 2015

    The Q&A for ICH Q7 has now entered the implementation state. Since the establishment of Q7 in 2000, uncertainties have arisen with regard to interpretation of sections concerning GMP of APIs. The new Q&A document seeks to harmonize regulatory expectations in this area.

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  • WHO Publishes Process Val Annex

    Jul 2, 2015

    WHO has published its final guidelines on nonsterile process validation in an appendix to its Technical Report Series 992. It outlines WHO’s support for linking process validation to Quality Risk Management and QbD principles.

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  • Final Guidance Available on Allowable Excess Volume in Vials

    Jul 2, 2015

    On June 25, U.S. FDA released its final guidance on requirements and regulations pertaining to allowable excess volume in injectable vials. This guidance also reinforces the importance of appropriate fill volumes and labeled vial fill sizes for injectable drug and biological products.

    This guidance replaces the 2014 draft guidance on the topic.

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  • Proposed Canadian Amendments Address Drug Shortages

    Jul 2, 2015

    Recent proposed amendments to Canada’s Food and Drugs Regulations would require manufacturers to provide notice to Health Canada six months in advance of a possible shortage or discontinuation of a drug product. This legislation follows an increase in shortages of medication within Canada over the past few years. In 2011, Canadian manufacturers created a voluntary, Web-based reporting system (www.drugshortages.ca).

    Comments on the amendments are due Sept. 2.

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  • WHO Releases Supplements to Temperature-Sensitive Product Guidance

    Jun 17, 2015

    WHO recently published 16 supplements to its 2011 guidance, Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products. These supplements offer principal requirements for safe storage and distribution of pharmaceutical products. Topics covered include storage facility design, temperature monitoring, temperature-controlled transport, shipping container qualification, management of refrigerant gases, among others.

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  • 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.

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  • 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.

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  • Reporting Requirements for CMC Changes

    Jun 2, 2015

    On June 1, the FDA released the draft guidance, Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products. This document outlines the Agency’s current thinking on what CMC information needs to be reported to the FDA in the event it is changed. In addition, the document provides recommendations for managing CMC changes over a product’s lifecycle.

    Comments are due July 31.

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  • FDA to Withdraw Unfinalized Guidances

    May 11, 2015

    The U.S. FDA recently announced plans to withdraw 47 guidance documents published prior Dec. 31, 2013 that remain unfinalized.

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