No Quick End To Brexit Activity Hold At EMA
As the European Medicines Agency gears up to implement its carefully crafted Brexit business continuity plan, it hopes to be in a position to reintroduce some of its currently suspended/reduced activities in the second half of next year.
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The European Medicines Agency is struggling to meet its 10-day turnaround for issuing certificates of pharmaceutical products (CPPs), documents that many countries outside Europe rely on to make their own regulatory decisions.
The EMA is halting its cherished transparency initiative on study data as it reckons with the fact that many of its employees will not be relocating to its new headquarters in Amsterdam. International collaboration, guidelines development and revision, and the agency's involvement in stakeholder meetings will all be cut back.
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.