• RoundupsRoundups

    Euro Roundup: EDQM pushes forward with ‘CEP of the future’ after positive feedback

    The European Directorate for the Quality of Medicines (EDQM) will spend the first half of 2022 designing the Certificate of Suitability (CEP) after a consultation revealed support for its plan to revise the content and layout document.   Companies working with active substances, raw materials, starting materials or excipients that are the subject of a European Pharmacopoeia monograph can request a CEP from EDQM and include the text in their applications instead of cert...
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    Euro Roundup: MHRA shares guidance on coordinated assessment pathway for device trials

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the coordinated assessment pathway it is piloting to streamline the review of clinical investigations involving medical devices.   MHRA and the Health Research Authority (HRA), which makes sure research is ethically reviewed and approved, are working together to test the pathway. The two organizations are sharing information on their assessments of medical device clinical investi...
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    Euro Roundup: EDQM says remote inspections could be third pillar for GMP oversight

    Real-time remote inspections piloted during the COVID-19 pandemic could serve as a third pillar for the supervision of active pharmaceutical ingredient (API) manufacturers, the European Directorate for the Quality of Medicines (EDQM) said.   EDQM began piloting real-time remote inspections, which it refers to by the abbreviation RTEMIS, in 2020 in response to travel restrictions. With the vast majority of the around 40 on-site inspections EDQM performs each year happen...
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    Euro Roundup: EU launches survey for COVID-19 drug developers

    The EU is holding a survey to understand the needs of companies developing new and repurposed treatments for COVID-19. The follows the European Commission’s recent strategy to support the approval of up to five new COVID-19 drugs by the end of the year.   (RELATED: EC strategy aims for 3-5 new COVID therapeutics by year end , Regulatory Focus 6 May 2021)   In the survey, the EU asks for information about the COVID-19 therapies companies are developing, includi...
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    Euro Roundup: Switzerland moves to mitigate split from EU on device regulation

    Switzerland has adopted supplemental provisions to its new Medical Devices Ordinance (MedDO) to soften the impact of its split from the European Union. The action comes as the failure to update a mutual recognition agreement (MRA) erects barriers to trade between Switzerland and the EU.   Swiss medical device manufacturers have enjoyed barrier-free access to the EU single market since 2001. However, the EU refused to consider updating the MRA in light of the new EU ...
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    Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars

    The European Medicines Agency (EMA) and European Directorate for the Quality of Medicines and Healthcare (EDQM) on Thursday released a report detailing findings from EMA’s drug sampling and testing program over the last 20 years.   EMA says it plans to extend the program to include biosimilars and that it will expand the generic sampling and testing program first launched in 2011 to include products authorized via the mutual recognition and decentralized procedures. ...
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    European Regulatory Roundup: CHMP Adopts Guidance on VTE Treatments (31 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Cardiovascular Working Party Signs off on Final Reflection Paper, Guidelines The Committee for Medicinal Products for Human Use (CHMP) has adopted a pair of final regulatory documents created by the Cardiovascular Working Party (CWP). Most significantly, the committee has adopted final guidelines on clinical trials of treatments for venous thromboembolism (VTE). Having bee...
  • With EDQM Absent, EFPIA Launching Own Anti-Counterfeit Strategy

    • 03 May 2012
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced it has signed on to a Memorandum of Understanding (MoU) that it says will help to set up a harmonized system of international standards to prevent counterfeit products from entering or proliferating within the pharmaceutical supply chain. EFPIA said the MoU, reportedly developed jointly between groups representing pharmacists, wholesalers and distributors, adopts what is known at the ...
  • EDQM Continuing Development of New, Comprehensive Anti-Counterfeiting Strategy

    • 18 April 2012
    The European Directorate for Quality in Medicines and Healthcare ( EDQM ), the Council of Europe's (EC) pharmaceutical standards body, announced it is continuing to develop and expand a new anti-counterfeiting strategy it says will reduce pharmaceutical-related crime. In its 18 April announcement, EDQM said the multi-layer legislative strategy aims to increase, among other things, training for inspection officials from EC member states, increased inspection and testing a...
  • Global API Inspection Scheme Continues to Ramp Up, Calls for Additional Members

    An active pharmaceutical ingredient (API) inspection program involving many of the world's premiere global regulatory bodies announced recently its intent to standardize the inspection schemes of the member nations and advance "administrative simplification." The as-yet-unnamed program, which includes the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Australia's Therapeutic Goods Administration (TGA), the World Health Organization (WHO), the...