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  • Regulatory NewsRegulatory News

    European Commission Consults on Revised GMPs for Sterile Drugs

    The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4 . The Commission says the revision was developed in cooperation with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and is meant to add clarity to Annex 1, which has been updated numerous times si...
  • Regulatory NewsRegulatory News

    EMA Gives Details on New Elemental Impurity Guideline

    The European Medicines Agency (EMA) has released its recommendations for implementing a newly adopted international standard for limiting elemental impurities in drug products. Background Elemental impurities are traces of metals that can end up in finished drug products. These impurities can come from multiple points in the manufacturing process, such as residual catalysts from a product’s synthesis or from contact with manufacturing equipment, containers and other m...
  • Regulatory NewsRegulatory News

    Australia’s TGA Issues Amended Nonclinical Studies Guidance

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued  an amended guidance on nonclinical studies for Module 4 of the  Common Technical Document  (CTD), which is an integral part of an application to register a prescription medicine on...
  • Regulatory NewsRegulatory News

    Digging Deeper into China's New Medical Device Registration Requirements

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Emergo Group colleagues in China have provided additional details on recently published changes to the China Food and Drug Administration’s (CFDA) medical device registration process. CFDA  Administrative Order No. 4  covers new and revised requirements for Class I, II and III device registrations in China that will take effec...
  • Regulatory NewsRegulatory News

    FDA Looks to Improve Generic Drug Submission Quality in New Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance document on the content and format of generic drug submissions using the common technical document (CTD). Background Generic drug applications are regulated under Section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) , and are submitted to FDA using an Abbreviated New Drug Application (ANDA). A successful application will show that a drug is the same (as defined by FDA) as ...
  • eCTD Revisions Published by FDA, Set for June 2014 Adoption

    In recent years, the electronic Common Technical Document (eCTD) has become the application type of choice for regulatory professionals operating in the US, EU, Japan and many other markets, offering them a relatively straightforward way to file small variations on a single application to multiple regulatory bodies. Now the US Food and Drug Administration (FDA) has announced the publication of final versions of several documents outlining specifications used in the eCTD's...
  • Health Canada Overhauls Guidance for eCTD Module

    Health Canada has released a new guidance document pertaining to the creation of the Canadian Module 1 backbone of the electronic Common Technical Document (eCTD), a standardized pharmaceutical review application format created by the International Conference on Harmonisation (ICH). Canadian regulators explained that the new guidance replaces an earlier 2004 guidance of a similar name, and outlines the process by which industry can create a regional backbone file. The fi...
  • 'Major Updates' to eCTD Module 1 Released by FDA

    The US Food and Drug Administration (FDA) has announced the release of "major updates" to Module 1 of the electronic common technical documents (eCTD), used to supplement all eCTD submissions in the US with specific information required by FDA. The two documents, The eCTD Backbone Files Specification for Module 1, version 2.0 and Comprehensive Table of Contents Headings and Hierarchy, version 2.0. , are available on FDA's website along with other supporting tec...
  • Feature ArticlesFeature Articles

    Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices

    This article reviews the current state of the development of quality system requirements for combination products, in particular prefilled drug delivery devices. As part of a series on US Food and Drug Administration (FDA) regulation of combination products, 1-9 it discusses industry's response to FDA's proposed rule on quality systems for combination products and how manufacturers of combination products should prepare for compliance with the anticipated final rule and ...
  • 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...
  • FDA Looks to Support Animal Rule With New GLP Training Program

    • 15 June 2012
    • By
    How do you ensure regulatory compliance in the world's most dangerous laboratory environments? The US Food and Drug Administration (FDA) wants to know, and is proposing to put money behind an initiative it says is aimed at supporting its 'Animal Rule' by developing an academic-based training program to educate pharmaceutical professionals working in high containment environments on good laboratory practices (GLPs). In an advanced posting of an 18 June Federal Register ...
  • CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new training module on a guidance document released by the agency that focuses on making benefit-risk determinations for medical device submissions. FDA's guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , was released 27 March 2012. FDA noted at the time of the guidance release ...