Science and Regulatory Affairs
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.
North America News
U.S. FDA Final Rule Amends Sterility Test Requirements for Biological Products
May 3, 2012
A final rule by the U.S. FDA has amended the sterility test requirements for biological products. The rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages the use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products.
The rule is effective on June 4.
U.S. FDA Releases Global Engagement Report
April 25, 2012
The U.S. FDA has released a report detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.
The Global Engagement Report outlines a variety of strategies the FDA is using in partnership with other agencies, organizations and coalitions around the world to strengthen global, regulatory capacity-building efforts, develop and harmonize science-based regulatory standards, increase awareness about the importance of regulatory systems and share information and data globally to facilitate rapid identification of and response to public health emergencies.
U.S. FDA Unveils Pre-Market Review Processes for Medical Devices in Guidance
March 28, 2012
The U.S. FDA has published a medical device guidance for manufacturers describing how the benefits and risks of certain medical devices are considered during pre-market review.
The guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, includes a worksheet for device reviewers that incorporates the principal factors that influence benefit-risk determinations, such as the type, magnitude and duration of a risk or benefit, the probability that a patient will experience the risk, patient tolerance for risk, availability of alternative treatments, and the value the patient places on treatment.
The FDA is also developing external training modules to help industry and device sponsors understand how the guidance will be applied.
U.S. FDA Publishes Medical Device Guidance
March 21, 2012
The U.S. FDA has published a guidance, entitled, Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program.
This guidance is intended to provide information on the implementation of the FDA Amendments Act of 2007 with regard to how an establishment which was audited under one of the regulatory systems implemented by the Global Harmonization Task Force founding members using ISO 13485: 2003.
The Agency may be able to use the audit results as part of their risk assessment program to determine if the establishment can be removed from FDA’s work plan for one year. The guidance will be part of a two year pilot program beginning June 5. Following the completion of the pilot program, FDA will evaluate the results and report on the findings and any issues or suggested changes.
U.S. FDA to Amend 21 CFR Part 5, Subpart M
March 20, 2012
On April 1 the U.S. FDA amended 21CFR Part 5, subpart M to reflect organizational change in the Agency and to make other conforming changes.
The action is editorial in nature and is intended to improve the accuracy of the Agency’s regulations. The alterations will not result in any substantive changes to the regulations themselves.
U.S. FDA Hosting Public Meeting Prior to ICH Meeting in Japan
March 14
On May 14, the U.S. FDA will host a public meeting in preparation for the International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Fukuoka, Japan in June.
The meeting will take place at FDA’s White Oak campus in Silver Spring, Md.
U.S. FDA Draft Guide Available on the Use of Phthalates
March 6, 2012
The U.S. FDA has released a draft guidance, entitled, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.
The draft guidance provides CDER’s current thinking on the potential human health risks associated with exposure to dibutyl phthalate and di(2-ethylhexyl) phthalate. In particular, the draft guidance recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients in CDER-regulated drug and biologic products, including prescription and non-prescription products.
Comments should be submitted by May 31.
USP Chapter on Supply Chain Integrity Proposed
March 2, 2012
The USP’s Pharmacopeial Forum has announced that a new general information chapter, called, <1083> Good Distribution Practices—Supply Chain Integrity has been proposed. The chapter will be a part of a series of informational chapters describing various aspects of the pharmaceutical supply chain. Specifically, <1083> will describe a set of recommended practices for helping to ensure supply chain integrity for drug components and drug products.
Comment by May 31.
U.S. FDA Releases Draft Guidance on Prescription Drug and Biological Product Shortages
February 27, 2012
The U.S. FDA has announced the availability of a draft guidance for industry entitled, Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage.
This draft guidance relates to the Federal Food, Drug, and Cosmetic Act, which requires sole manufacturers to notify FDA of a discontinuance of certain drug products and to the President’s Executive Order 13588 of October 31, 2011, directing FDA to use all available administrative tools to expand the Agency’s efforts to combat the problem of drug shortages.
Comment by May 29.
U.S. FDA Releases Q&A Draft Guide on PET Drug Products
February 27, 2012
The U.S. FDA has released a draft guidance, entitled, FDA Oversight of PET Drug Products—Questions and Answers. The draft guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes for PET drug products, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees.
Comment by May 29.
U.S. FDA Releases Three Draft Guidances on Biosimilars
February 15, 2012
The U.S. FDA has announced the availability of three draft guidance documents on biosimilar products.
The Scientific Considerations in Demonstrating Biosimilarity to a Reference Product draft guidance is intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting an application.
The Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product draft guidance provides an overview of analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product for the purpose of submitting a 351(k) application.
The Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 draft guidance provides answers to common questions from people interested in developing biosimilar products.
The documents provide the Agency's current thinking on key scientific and regulatory factors involved in submitting biosimilar applications under the abbreviated approval pathway that was approved in March 2010.
Comments are due by April 16.
U.S. FDA Draft Guidance on IND Applications for PET Drugs Available
February 14, 2012
A U.S. FDA draft guidance on investigational new drug (IND) applications for positron emission tomography (PET) drugs is now available.
The draft guidance is intended to assist manufacturers of PET drugs in submitting IND applications. The draft guidance summarizes the IND process for PET drugs, makes recommendations for how to submit an IND, provides advice on expanded access options for investigational PET drugs, and describes the process for requesting permission to charge for an investigational PET drug.
Comments should be submitted by May 14.
Draft Guidance Released on Heparin for Drug and Medical Device Use
February 13, 2012
The U.S. FDA has released a draft guidance, entitled, Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality. The draft guidance is intended to alert manufacturers of active pharmaceutical ingredients, pharmaceutical and medical device manufacturers of finished products, and others to the potential risk of crude heparin contamination.
The document provides recommendations to better control the use of crude heparin that might contain oversulfated chondroitin sulfate (OSCS) or non-porcine material (especially ruminant material) contamination and suggests strategies to test for contamination.
The draft guidance should be used in addition to the USP monograph testing required for other forms of heparin to detect the presence of OSCS.
Comments are due by April 13.
Comment on U.S. FDA's Medical Device Recall Authority Provision
February 13, 2012
The U.S. FDA is requesting comments on a medical device recall authority provision collection of information.
The provision grants the Agency with the authority to issue an order requiring an appropriate person to immediately cease distribution of a device, immediately notify health professionals and device-user facilities of the order and instruct them to cease use of such device, if FDA finds that there is reasonable probability that the device intended for human use would cause serious adverse health consequences or death.
It also sets out a three-step procedure for a mandatory device recall order.
The information collected under the recall authority provisions will be used by FDA to:
- Ensure that all devices entering the market are safe and effective
- Accurately and immediately detect serious problems with medical devices
- Remove dangerous and defective devices from the market
Comments are due by March 12.
U.S. FDA Releases Product-specific Bioequivalence Recommendations
January 25, 2012
The U.S. FDA has provided draft and revised draft product-specific bioequivalence (BE) recommendations on the design of BE studies to support abbreviated new drug applications.
The BE recommendations identified were developed using the process described in the Bioequivalence Recommendations for Specific Products draft guidance.
Comments are due March 26.
U.S. FDA Completes Recommendations for User Fee Programs
January 13, 2012
The U.S. FDA announced that it has completed its recommendations for three user fee programs. The programs include the fifth authorization of the Prescription Drug User Fee Act (PDUFA), and new user fee programs for human generic drugs and biosimilar biological products.
The recommendations were transmitted to Congress on January 13.
U.S. FDA Requests Comments on the Labeling of Human Prescription Drugs, Biological Products
January 3, 2012
The U.S. FDA requests comments on a proposed information collection. Related to the requirements on the content and format of labeling for human prescription drug and biological products, this collection of information correlates to the requirement of the Final Rule published on January 24, 2006
The Agency asks for the accuracy of FDA's estimate of the burden imposed by the requirements, ways to enhance the collection and ways to minimize the burden on respondents.
Comments should be submitted by February 17.
U.S. FDA to Amend Postmarketing Reporting Regulations
January 3, 2012
The U.S. FDA has made an interim final rule amending the postmarketing reporting regulations so that sole manufacturers of certain drug products need to notify FDA at least six months before discontinuance of manufacture of the products.
The rule also broadens the reporting requirements by modifying certain definitions and enables the collection and distribution of drug shortage information to physicians and patient organizations.
The interim final rule is effective January 18. Comments should be submitted by February 17.
U.S. FDA Issues Report on Improving Guidance Document Development
January 3, 2012
The U.S. FDA has issued a report on some of FDA's best practices and makes recommendations on improving guidance document development.
The report, entitled, Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency was prepared in response to one of the action items associated with FDA's transparency initiative.
Comments are requested by February 28.
Europe News
EMA Releases Reflection Paper on Classification of ATMPs
April 30, 2012
The European Medicines Agency has released a reflection paper on the classification of advanced-therapy medicinal products (ATMP).
The ATMP classification is based on the evaluation of whether a given product fulfills one of the definitions of gene therapy medicinal product, somatic cell therapy medicinal product or tissue engineered product and whether the product fulfills the definition of a combined ATMP or not.
The ATMP classification is a non-mandatory, free of charge, legally non-binding procedure that helps developers to clarify the applicable regulatory framework. It also provides clarity on the development path and scientific-regulatory guidance to be followed.
The deadline for consultation is July 31.
European Medicines Agency’s eSubmission Gateway Goes Live
April 23, 2012
Following a successful pilot, the European Medicines Agency’s eSubmission Gateway is now live.
The eSubmission Gateway allows applicants to submit documents supporting all types ofcentralized marketing authorizations for human medicines to the Agency securely over the internet in eCTD format.
In parallel to the eSubmission Gateway project, the Agency is also running a pilot of an electronic application form for certain types of application for human and veterinary medicines.
EMA Draft Guideline on Process Validation released for consultation
April 13, 2012
The European Medicines Agency released a revised draft guideline on process validation. This new guideline replaces the current Note for Guidance on Process Validation and attempts to bring the EMA guidance on process validation in line with ICH Q8, Q9 & Q10. It also provides the possibility to use continuous process verification in addition to, or instead of, traditional process verification as described in the previous guideline.
The deadline for consultation is October 31.
EMA Launches Electronic Application Form Pilot Program
March 12, 2012
The European Medicines Agency has launched an electronic application form pilot program for submissions of centralized marketing authorization applications.
The pilot will run until mid-July 2012 and allow pharmaceutical companies to apply for initial marketing authorization application for human medicines as well as variation and renewal applications for human and vet medicines using an interactive PDF form.
The pilot is a key step forward in the Agency's drive towards the use of electronic applications in the Electronic Common Technical Document format. This is expected to simplify and speed up the application process.
EMA Expands International Collaboration on GMP Inspections
March 12, 2012
The EMA has announced it will expand its international collaboration on GMP inspections to include the World Health Organization (WHO) through its Prequalification of Medicines program.
Prior to recent expansion, the program involved EU Member States, the European Directorate of the Quality of Medicines and Healthcare, the U.S. FDA and the Australian Therapeutic Goods Administration.
Based on the positive experience from a pilot running from December 2008 until December 2010, the participants agreed to continue the collaboration.
EC to Update Volume II of EudraLex
March 12, 2012
The European Commission has announced it will update EudraLex - Volume II - Pharmaceutical Legislation, Medicinal Products for Human Use.
Volume II contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics, package information and classification for the supply, readability of the label and package leaflet requirements.
EMA Reflection Paper: Use of Starting Materials, Intermediates in Manufacturing of Biological Medicinal Products
February 27, 2012
The European Medicines Agency has released a reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products.
The documents addresses to what extent any variability may be acceptable in the early manufacturing steps for biological medicinal products which contain active substance extracted from organs, tissues or fluids from living organisms and for which flexibility of sourcing in the biological starting materials may be needed to ensure product supply. This document also clarifies the definition of starting materials for these products. A number of major examples are given which illustrate the concept of accepting process variability. Advanced Therapy Medicinal Products are excluded from the scope of this document.
The consultation deadline is August 31.
EMA Releases 7 of the 16 GVP Requirements
February 22, 2012
The European Medicines Agency has released seven of the sixteen modules of the new good pharmacovigilance practice (GVP) requirements in Europe.
The remaining nine draft modules making up the entire GVP package are under development and will be released for consultation later in the year. The Agency intends to finalize and publish these modules by July 2012, after comments from stakeholders have been taken into account.
Comments are due on the following modules by April 18:
- Pharmacovigilance systems and their quality systems
- Pharmacovigilance system master file
- Risk management systems
- Management and reporting of adverse reactions to medicinal products
- Periodic safety update report
- Post-authorization safety studies
- Signal management
TGA Requests Comments on Streamlined Submission Process as Part of Revision to Prescription Medicines Regulation
January 24, 2012
Australia's Therapeutic Goods Administration (TGA) is asking for comments on its streamlined submission process project, which will improve submission quality and provide predictable timeframes for the evaluation and registration of prescription medicines in Australia.
Some of the key differences between the streamlined submission and the previous process can be found in the pre-submission phase, submission quality and in the submissions themselves.
The project is part of the business process reforms program the TGA is undertaking to regulate prescription medicines in Australia.
EC Requests Consultation on Extending GMP to Active Substances
January 20, 2012
The European Commission (EC) is requesting comments on its concept paper on extending the GMP for medicinal products to cover active substances.
The concept paper is part of the implementation of Directive 2011/62/EU which requires the Commission to adopt, by means of a delegated act, the principles and guidelines of good manufacturing practice for active substances. Adoption of the GMP rules from this process is planned for 2013.
Comments are requested by April 20.
EMA Issues Draft Guidance on how to Evaluate Potential Risks via a Risk-based Approach in ATMPS
January 19, 2012
The European Medicines Agency has issued a draft guideline on how to evaluate potential risks via a risk-based approach in advanced therapy medicinal products (ATMPS).
The aim of the risk-based approach is to help the applicant of a Marketing Authorisation Application (MAA) determine the extent of quality, non-clinical and clinical data that should be included in the MAA. It is anticipated that on completion of the profiling of the identified risks/risk factor combinations, a specific profile for each risk can be concluded.
The deadline for comments is June 30.
EMA Draft Guideline on the Use of Near Infrared Spectroscopy Released
January 20, 2012
A draft guideline on the use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations has been released by the EMA.
The guideline describes the regulatory requirements for marketing authorization applications and variation applications submitted for medicinal products for human or veterinary use, which include the use of NIRS. It also outlines the requirements for applications in which NIRS is used for qualitative and quantitative analysis or where it is used as a process analytical technology for monitoring and controlling drug substance synthesis and finished product manufacturing processes.
Comments are due by May 31.
Danish Medicines Agency Clarifies Active Substance Master File Process
January 17, 2012
The Danish Medicines Agency has released a document on its website clarifying the process of updating an active substance master file (ASMF) for marketing authorization holders (MAH).
For example, the document specifies that the active substance manufacturer is required to inform the MAH when changes are made to the applicants' part and/or the restricted part of the ASMF. The MAH is responsible for applying for these changes in order for them to be implemented in the marketing authorization.