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  • Regulatory NewsRegulatory News

    EMA’s Pediatric Committee Seeks to Tweak ICH Q&A on Nonclinical Evaluation of Cancer Drugs

    The European Medicines Agency’s (EMA) Pediatric Committee has offered a couple of comments, slight tweaks and further suggestions for the International Council for Harmonisation’s (ICH) draft question and answer document on its S9 guideline on the nonclinical evaluation for anticancer pharmaceuticals. The committee points to a couple of references in the Q&A on S9 on the scope of the guideline and the statement that "the need for juvenile toxicity testing sho...
  • FDA Goes into Detail About Generic Drug Stability Testing

    A new guidance document released by the US Food and Drug Administration (FDA) aims to answer some common questions regarding stability testing used to support generic drug applications. Background The guidance, ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers , is a follow-up to a draft guidance released in September 2012 , and then finalized in June 2013 . The stability studies are intended to ensure that a product maintains its pot...
  • ICH Looks to Clarify 'Key Issues' With E2C Adverse Event Reporting Guideline

    In 2012, the International Conference on Harmonisation (ICH) released a new guideline, E2C (R2) - Periodic Benefit-Risk Evaluation Report , meant to ensure that PBRERs-standardized adverse event reports-contain the information regulators need to evaluate side effects and, if needed, take action. Now ICH is out with an accompanying Question and Answer document on the E2C guideline, a document it says is intended to "clarify key issues" that have cropped up since the ...
  • FDA Releases Extensive Final Q&A Guidance on Generic User Fees

    The US Food and Drug Administration (FDA) has released an updated question-and-answer document intended to assist sponsors and manufacturers of generic drug products approved via the 505(j) regulatory pathway with paying statutorily mandated user fees under the Generic Drug User Fee Act (GDUFA) . Background FDA is relatively unique among federal agencies in that the majority of its funding comes not from congressional appropriations, but rather from industry-paid user ...
  • FDA Clarifies Stability Testing Requirements for Generics with New Draft Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance meant to clarify the agency's expectations about abbreviated new drug applications (ANDAs) and the stability testing used to support those applications. Background Under the 1984 Hatch Waxman Act , drug manufacturers were given the ability to compete with innovative drug applications originally filed through the new drug application (NDA) approval pathway. Under the act, innovative products wer...
  • Japan: PMDA Provides Updated Guidance on Conducting Global Clinical Trials

    Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has issued a newly-updated Q&A document that revises its 2007 guidance on conducting international clinical trials.   PMDA recommends that companies use the document, Basic Principles on Global Clinical Trials (Reference Cases), prior to engaging the agency in consultations on proposed clinical trials. In its notice, PMDA explains that the document reflects the experience the agency has gained...
  • FDA Adopts ICH Guidance on Pharmaceutical Quality

    The US Food and Drug Administration (FDA) released new guidance on 25 July for industry regarding three quality documents released by the International Conference on Harmonization (ICH) related to how manufacturers and sponsors can best prepare these documents for inspection by regulators in the US, EU and Japan. The guidance is co-sponsored by FDA's Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), both of which are in charge ...
  • ICH Publishes New Guideline on Clinical Study Reports

    The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released a new question and answer document for its E3: Structure and Content of Clinical Study Reports ("The E3 Guideline") guideline. Writing on 21 June 2012, ICH said the document was finalized in mid-June as part of Step 4 of its Q&A Procedure process, indicating the document has reached consensus status and is in the proces...
  • EMA Releases Guidance on Electronic Submission of Veterinary Applications

    The European Medicines Agency (EMA) released a new question and answer guidance document on 22 May to assist sponsors with submitting their veterinary dossiers in an electronic format. The document, Electronic submission of veterinary dossiers: Questions and answers , provides answers to a number of common questions. Sponsors submitting via the centralized application procedure are encouraged-but not required-to submit their veterinary dossiers to EMA, though sponsor...
  • EMA Publishes Updated Guidance on Premarketing, Postmarketing Procedures

    The European Medicines Agency (EMA) has released updated guidance on procedural advice for its post-authorization and pre-authorization procedural advice, providing regulatory professionals with comprehensive and integrated lists of the answers to most questions regarding the authorization procedure. EMA's 26 April guidances cover questions and answers applicable to the pre- and post-submission timeframes, and are frequently updated. Read more: European Medicines A...
  • EMA Posts Revised Integrated Guidance on Use of Centralized Procedure

    The European Medicines Agency (EMA) has released a revised integrated guidance document containing advice for user of the centralized procedure. EMA's 18 April revision of the Q&A document represents its 21 st revision, and is a comprehensive resource including information from a wide range of regulations and guidances. "This guidance document addresses a number of questions which marketing authorization holders (MAHs) may have on post-authorization procedures," ex...
  • EMA Releases New Biosimilar Q&A Guidance

    The European Medicines Agency (EMA) has published a new guidance document that brings together in a single place a number of regulatory and procedural questions on biosimilars.  It provides an overview of the agency position on issues which are typically addressed during Pre-Submission Meetings. The agency notes that the document is for procedural advice only, and should be read in conjunction with the "Notice to Applicants" in the agency's Rules Governing Me...