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  • Regulatory NewsRegulatory News

    Germany Reimbursement Profile

    This profile summarizes the reimbursement process in Germany, presents responsibilities for key stakeholders and highlights issues for consideration early in the development process. Obtaining regulatory approval for medicines is the first major hurdle of most pharmaceutical and biotechnology companies wanting to launch their products worldwide. However, obtaining market access once products are approved by regulatory agencies is a separate and crucial process without ...
  • Regulatory NewsRegulatory News

    Following Negative Comments by Reviewer, EU Committee OK's Gene Therapy

    Last month, German regulators postponed their review of UniQure's gene therapy Glybera after the European Medicines Agency (EMA) rapporteur assigned to the product claimed new data showed Glybera lacked efficacy and called for it to be reassessed . Now, EMA's Committee for Advanced Therapies (CAT) has completed its assessment, and is maintaining its positive opinion of Glybera, Reuters reports. Background Glybera is the first gene therapy approved for use in the E...
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    German Regulators Decry Lack of Trial Transparency in Look at Stem Cell Transplantation

    The German Institute for Quality and Efficiency in Health Care (IQWiG) has found recent clinical data on the use of stem cell transplantation to treat multiple myeloma—a rare and deadly form of cancer—to be inconclusive . Background and 2012 Conclusion Stem cell transplantation is a therapy used to treat certain cancers, immunodeficiencies and hematologic diseases. It has also been widely used to treat multiple myeloma. Patients undergoing stem cell transplantation a...
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    First EU-Authorized Gene Therapy Hits Snag, Benefit Assessment Delayed in Germany as EMA Reviews New Report

    Regulators at the German Federal Joint Commission (G-BA) have postponed their review of the gene therapy Glybera, Reuters reports . The decision was made after the European Medicines Agency (EMA) rapporteur assigned to Glybera found the product lacked efficacy and called for it to be reassessed. Glybera, which treats a rare condition called lipoprotein lipase deficiency (LPLD), made headlines both for being the first gene therapy approved in Europe and for its record-...
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    German Price Watchdog Says ‘No’ to 3 Cancer Drugs

    The Institute of Quality and Efficiency in Healthcare (IQWiG) gave negative assessments for three recently approved cancer drugs this month. IQWiG is one of several bodies in Germany charged with conducting health technology assessments (HTAs) for newly approved drugs in Germany. The goal of these assessments is to weigh the benefit of new therapies against the costs to the country’s healthcare system. According to IQWiG’s assessment, the drugs idelalisib , sipuleucel...
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    Anvisa Updates BA, BE Test Best Practices Certification

    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. Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies.  The practices are those that must be adopted by research centers in order to ensure their BA/BE studies—comparing pharma...
  • Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs

    The US Food and Drug Administration (FDA) has published a new draft guidance recommending various approaches when conducting bioequivalence (BE) and bioavailability (BA) studies in support of new and investigational drug applications. What Does FDA Mean by BA/BE? BA refers to the extent to which a drug is absorbed into the body and is thus available to act upon the drug's intended target, also known as the "site of action" (21 CFR 320.1[a]). For example, if a drug is in...
  • India’s CDSCO Says Bioequivalence Testing Centers Require Approval

    India's Central Drugs Standard Control Organization (CDSCO) issued a "clarification" to local authorities that laboratories intending to engage in bioequivalence and bioavailability (BA/BE) testing must first obtain the approval of the CDSCO before engaging in such activities.  In the clarification, the CDSCO notes that BA/BE study results will only be recognized if they are conducted by approved facilities.  Moreover, the same approval requirement extends t...
  • Brazil Suspends Certification Process for Foreign Bioequivalence and Bioavailability Test Centers

    Brazil's National Agency for Sanitary Surveillance (Anvisa) has suspended processing of new applications for primary certification of bioavailability or bioequivalence for medical products by research centers located outside the country. Applications filed prior to 31 July 2013, the date the suspension entered into force (RDC 37/13), will still be processed, regulators said. The purpose of the suspension is to facilitate the review of existing rules governing foreig...
  • Teva Withdraws Antidepressant After Bioequivalence Concerns Validated by FDA

    The US Food and Drug Administration (FDA) has asked Israeli generic drug manufacturer Teva Pharmaceuticals to stop distribution of Budeprion XL 300, a generic version of the antidepressant Wellbutrin XL 300, after becoming aware of significant differences between the two drugs. The request-agreed to by Teva-comes five years after a similar review conducted by FDA came to the opposite conclusion. In 2007, FDA conducted a review of the therapeutic equivalence between...