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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Report Calls to Minimize Amount of Data Generated by Sponsors (28 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Report Calls on Regulators, HTAs to Minimize Sponsor Data-Generation Requirements The European Parliament’s policy department has published a report recommending regulators and health technology assessment (HTA) bodies take steps to minimize the amount of data demanded of drug developers. Members of the Directorate for Economic and Scientific Policies made the proposal in...
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    European Regulatory Roundup: Ireland to Offer Regulatory Advice via New Innovation Office (17 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Ireland Creates Innovation Office to Provide Regulatory Advice The Health Products Regulatory Authority (HPRA) of Ireland has created an Innovation Office to give advice to developers of novel health products and technologies. HPRA sees the office facilitating the timely development of innovative interventions by providing regulatory input early in the process. Staff ...
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    EMA Recommends Nine Drugs for Approval

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics. As for the new medicines, CHMP recommended granting a marketing authorization to CSL Behring’s Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with hemophilia A, Novo Nodisk’s Fiasp (...
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    EMA’s CHMP Recommends Ban of US CMO’s Medicines

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday recommended that medicines manufactured by Maryland-based contract manufacturing organization (CMO) Pharmaceutics International (Pii) should no longer be available in the EU, except for Ammonaps (sodium phenylbutyrate), which is used to treat a rare disease and is considered critical for public health. The recommendation follows a good manufacturing practice (GMP) review afte...
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    European Regulatory Roundup: GPs Create Expert Group to Liaise With EMA (5 May 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Posts Draft Guideline on Clinical Trials of Acute Coronary Syndrome Treatments The European Medicines Agency (EMA) has released a draft guideline about the clinical development of treatments for acute coronary syndrome (ACS). EMA drafted the text to update a pair of existing guidance documents, which have been rendered outdated by advances in the diagnosis, treatme...
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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...
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    European Regulatory Roundup: Lilly May Move API Production Outside EU Due to REACH Regulations (17 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Eli Lilly Threatens to Move API Production out of the EU in Broadside Against REACH Eli Lilly has warned it may move production of certain active pharmaceutical ingredients (APIs) out of the European Union because of REACH regulations. The production of two of Lilly’s veterinary APIs is tied to the availability of cobalt salts, something it says is becoming a “significant pr...
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    EMA Takes a Firmer Stance on GCP Non-Compliance

    Drug and biotech companies cannot replace pivotal clinical trials that are non-compliant with good clinical practice (GCP) standards during the assessment of marketing authorization applications, according to a new position paper from the European Medicines Agency (EMA). Stressing the importance of GCP compliance, the EMA says it’s an “essential prerequisite” for assessing a medicinal product’s safety and efficacy. The agency also clarifies that when a study is found to...
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    European Regulatory Roundup: MHRA Phasing Out Use of CDs, DVDs in Submissions (30 November 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA to Stop Accepting Submissions on Physical Media in February The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is to stop accepting submissions for medicines licenses on physical media on 1 February 2016. MHRA has decided to drop support for physical media after talking to trade groups about the use of the format. Having completed the...
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    European Regulatory Roundup: EMA Unveils Antimicrobial Strategy (19 November 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Releases Five-Year Antimicrobial Strategy The European Medicines Agency (EMA) has released a document outlining how it plans to ensure the availability of effective antimicrobials for animals while minimizing the risks their use poses to humans. EMA is proposing to restrict the administration of certain antimicrobials to humans. Over the course of the 16-page doc...
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    European Regulatory Roundup: Dutch Regulator Revamps Drug Nomenclature Policy (22 October 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Dutch Regulator Overhauls Policy on Nomenclature of Medicines The Medicines Evaluation Board (MEB) in the Netherlands has completely revised its policy on nomenclature covering human medicinal products and is enforcing the changes with immediate effect. Out of all the revisions included in the new nomenclature policy, MEB has picked out six that it sees as the most importan...
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    European Regulatory Roundup: CHMP Updates Breast Cancer Guidelines (15 October 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Updates Data Quality Control, IT Papers as Introduction of New Process Nears The European Medicines Agency (EMA) has updated documents on data quality control and electronic filings ahead of the introduction of a new process in November. EMA will start using the new process on 4 November, at which time the regulator will start sending out alerts every time it vali...