RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    MHRA issues post-transition orphan, Northern Ireland supply guidance

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued post-transition guidance on orphan medicines designations and incentives, as well as guidance on supplying medicines from Great Britain to Northern Ireland.   The guidances are the latest in a suite of post-transition guidance from the agency as it prepares for the Brexit transition period to expire at the end of the year. (RELATED: MHRA posts suite of post-transition guidances , ...
  • Regulatory NewsRegulatory News

    MHRA launches dedicated COVID-19 Yellow Card site

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday launched a dedicated site for reporting side effects and incidents related to medicines and medical devices used in patients infected with SARS-CoV-2, the novel coronavirus that causes COVID-19.   The COVID-19 Yellow Card reporting site is meant to “enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects ...
  • RoundupsRoundups

    EU Regulatory Roundup: Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers   Ireland’s Health Products Regulatory Authority (HPRA) has reported an almost four-fold increase in its annual number of marketing authorization holder (MAH) transfers. The jump covers the run up to the date on which the United Kingdom was originally due to leave the European Union.   In...
  • RoundupsRoundups

    EU Regulatory Roundup: CHMP Questions Delay Novartis Gene Therapy Approval Timeline

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   CHMP Questions Delay Novartis Gene Therapy Approval Timeline   Tougher than expected regulatory scrutiny has delayed Novartis’ efforts to bring its spinal muscular atrophy gene therapy Zolgensma to patients in Europe. Novartis had hoped to win approval by the end of the year, but now expects the Committee for Medicinal Products for Human Use (CHMP) to deliver its op...
  • Regulatory NewsRegulatory News

    MHRA Offers No-Deal Brexit Guidance on Comparator Products for Generic Drug Studies

    As another delay may push back Brexit to the end of January, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday published new guidance on comparator products (CPs) used in bioequivalence (BE), pharmacokinetic (PK) and therapeutic equivalence (TE) studies to support generic drug and other abridged marketing authorization applications following a no-deal Brexit. The guidance explains how it may be possible for an applicant to compare a proposed...
  • Regulatory NewsRegulatory News

    UK Alerts to Teva Recall of Heartburn Medicines Over Impurity Fears

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday alerted to a recall of its heartburn medicine ranitidine following similar recalls due to possible contamination with an impurity called NDMA (N-nitrosodimethylamine), which may increase the risk of cancer. For health professionals, the MHRA says to stop supplying the products immediately and quarantine all remaining stock and return it to suppliers. Andrew Gray, MHRA deputy director of...
  • RoundupsRoundups

    EU Regulatory Roundup: UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup   The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit.   ...
  • RoundupsRoundups

    EU Regulatory Roundup: Ireland’s HPRA Floats Fee Increases as Brexit Creates Challenges

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland’s HPRA Floats Fee Increases as Brexit Creates Challenges   Ireland’s Health Products Regulatory Authority (HPRA) is planning to introduce new fees and increase existing charges. HPRA framed the fee increases in light of the increasingly challenging environment in which it operates, pointing to Brexit, new medical device rules and an increase in the complexit...
  • Regulatory NewsRegulatory News

    UK Updates on Drug Shortage Plans Ahead of Looming Brexit Deadline

    Although the UK has prepared for drug supply issues ahead of a no-deal Brexit on 31 October, Matt Hancock, UK secretary of state for health and social care, explained recently what still needs to be done. Chief among the issues that need to be dealt with is industry readiness for the new customs procedures under a no-deal Brexit and ensuring that industry registers to access new freight capacity. “The Government is establishing a dedicated trader readiness ‘Support U...
  • Regulatory NewsRegulatory News

    With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports

    As part of efforts to prevent drug shortages ahead of a possible no-deal Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday published a list of 24 medicines that cannot be parallel exported from the UK. The list includes drugs like the hormone therapies estradiol and levonorgestrel, the antiviral oseltamivir, adrenaline, the blood thinner rivaroxaban and the high blood pressure medicine prazosin, among others. The reason why the UK...
  • RoundupsRoundups

    EU Regulatory Roundup: EMA Expands Nitrosamines Investigation to All Chemically Synthesized APIs

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EMA Expands Nitrosamines Investigation to All Chemically Synthesized APIs   The European Medicines Agency (EMA) has asked manufacturers of medicines made with chemically synthesized active pharmaceutical ingredients (APIs) to test their products for nitrosamines. EMA’s request follows the discovery of the carcinogenic contaminants outside the sartan class of drugs. ...
  • RoundupsRoundups

    EU Regulatory Roundup: Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply   Ireland’s Health Products Regulatory Authority (HPRA) has shared details of its work to mitigate the risk that a no-deal Brexit will disrupt the supply of medical devices. HPRA wants companies to consider their stocking levels and make arrangements to ensure they can replenish their supp...