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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Industry Seeks Post-Brexit System Prioritizing Ties to EMA (31 August 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Industry Asks UK Government for Post-Brexit System That Prioritizes Ties to EMA Over Flexibility The United Kingdom life sciences industry has asked the government to prioritize maintaining close ties to regulators in Europe as it shapes the post-Brexit landscape. Offered the choice between seizing potential regulatory flexibilities created by splitting from the Euro...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance describing the conditions under which companies can use an alternative reporting format to satisfy postmarketing safety reporting requirements. The guidance explains the intricacies of how applicants can use an alternative reporting format, known as the International Council for Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in place of the US periodic adverse drug expe...
  • Regulatory NewsRegulatory News

    MHRA: Safety Updates Will No Longer be Submitted to National EU Regulators Beginning in June

    From 13 June 2016 onward, companies across Europe will no longer submit periodic safety update reports (PSUR) to national regulators but instead to a central repository at the European Medicines Agency (EMA). The repository was created under legislation introduced in July 2012 and also provides for the storage of associated assessment reports, additional data and comments. “This will apply for all products including those only approved in the UK. From 13 June 2016 the...
  • Regulatory NewsRegulatory News

    New Drug Safety Monitoring Fees Come Into Effect in Europe

    User fees paid by pharmaceutical companies, intended to fund regulatory activities by offsetting their expense, are set to rise in Europe under a new regulation published this week. The fees are intended to pay for new pharmacovigilance activities—basically the monitoring of medicines after their initial approval—that were required under legislation passed in 2010 and amended in 2012. The law, known as the pharmacovigilance legislation , is intended to centrali...
  • 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 ...
  • EMA to Conduct Safety Review of EU and Nationally Approved Drugs

    The European Medicines Agency (EMA) has announced a milestone safety review of drugs approved through both the centralized EU procedure and the national procedure, based on the active substance that a drug contains. The review is slated to begin on 1 April 2013. Until now, the agency's review of the safety of marketed drugs has been limited to medicines authorized through the centralized procedure.  EMA's expanded authority to undertake such a review was granted ...
  • Report: India to Withdraw Any Drug Not Marketed Within Six Months of Approval

    • 16 January 2013
    • By
    India's primarily drug regulatory body, the Central Drugs Standard Control Organization ( CDSCO ), has notified all of its state licensing authorities that any drug product that fails to launch within six months after its approval should have its permissions and licenses to market canceled, reports PharmaBiz . The move loosely mirrors the practices of other regulatory bodies, including the US Food and Drug Administration (FDA), which can withdraw exclusivity for s...
  • EMA Asks for Feedback on Pharmacovigilance Legislation Implementation

    The European Medicines Agency (EMA) is calling on industry to comment on its draft list of European Union reference dates for Period Safety Update Reports (PSURs) that are being implemented as a result of the recent pharmacovigilance legislation. "The purpose of the consultation is to ensure completeness and correctness of the information before the list is adopted later this year," said EMA in a prepared statement released 4 April. "The list is intended to optimize the...