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  • Regulatory NewsRegulatory News

    ICMRA outlines shape of Phase 3 COVID-19 vaccine trials

    A new report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2, the virus that causes COVID-19. The report indicates which clinical and preclinical data will indicate a vaccine is ready for Phase 3 trials; it also lays out key considerations in designing Phase 3 clinical trials of vaccines for COVID-19.   The report reflects consensus reached at a 22 June 2020 teleconference convened by the US Foo...
  • ReconRecon

    Recon: Takeda in for $900M on gene therapy R&D; Vertex gets quick win in England for CF triple therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gottlieb says worst of outbreak will pass by January; Pence sees no need for a mask mandate ( CNBC ) Coronavirus Update: Spooked By America’s COVID-19 Vaccine Skepticism, FDA Promises Not To Lower Standards ( Scrip ) AHA: Hospital losses could top $323B in 2020 ( HealthLeaders ) 2020 Fortune/IBM Watson Health 100 Top Hospitals List ( HITConsultant ) EUSA P...
  • Regulatory NewsRegulatory News

    EMA recommends eight new medicines, refuses one

    A committee of the European Medicines Agency (EMA) recommended that eight new medicines be approved at its June meeting, and issued a negative opinion on an anti-tumor drug.   The human medicines committee (CHMP) of EMA recommended a refusal of the marketing authorization for Daiichi Sankyo’s Turalio (pexidartinib), which was to be used to treat tenosynovial giant cell tumors. The agency cited concern for small improvement in clinical outcomes and uncertainty about dur...
  • Regulatory NewsRegulatory News

    International regulators iron out COVID vaccine trial harmonization

    As more candidate vaccines for the novel coronavirus are progressing to advanced clinical trials, international regulators are planning for international convergence on the nuts and bolts of what is needed to move to phase 3 trials of COVID-19 vaccines. On Monday, a group of regulators were convened under the umbrella of the International Council of Medicines Regulatory Authories (ICMRA) for a multinational discussion. In all, 100 regulators from more than 20 countries ...
  • Regulatory NewsRegulatory News

    EMA offers free orphan drug advising to academia

    Academic organizations working on drug development for rare diseases will now be eligible for waiver of fees for scientific advice from the European Medicines Agency (EMA), according to an updated Executive Decision issued by the agency. “The academic sector plays an important role in the development of innovative medicines. Their scientific research is often at the source of novel methodologies and innovative medicines with the potential to benefit patients with rare d...
  • Regulatory NewsRegulatory News

    New priorities set for trans-Atlantic collaboration on medicines

    As part of an annual bilateral regulatory dialog, officials from the European Commission (EC), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) agreed on priorities for collaboration.   “In the context of the  COVID-19 pandemic , the EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA),” said EMA in...
  • Regulatory NewsRegulatory News

    EMA affirms ACE inhibitors, ARBs safe during COVID-19

    The European Medicines Agency (EMA) has issued a statement reiterating that people should continue to take certain blood pressure medicines during the COVID-19 pandemic. Recent observational studies, the agency said , have not shown that taking angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) increases the risk of contracting the novel coronavirus or worsening illness for people with COVID-19. The statement reaffirms EMA’s previous...
  • Regulatory NewsRegulatory News

    EMA strengthens ENCePP mandate to address COVID-19 pandemic

    The European Medicines Agency (EMA) has strengthened the mandate for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), creating a COVID-19 Response Group working within ENCePP to aid in pharmacovigilance and pharmacoepidemiology work amid the pandemic. EMA said the new mandate is necessary to address “unprecedented challenges for the epidemiological and regulatory communities” in addressing COVID-19. “This role would give ENCePP ...
  • Regulatory NewsRegulatory News

    Multinational efforts build framework for real-world and observational COVID-19 data

    International regulators will increase cooperation for observational studies conducted in three key eras during the coronavirus pandemic.   Building a strong infrastructure to monitor vaccine safety and effectiveness, putting together international clinical cohorts of patients with COVID-19 infection and pregnancy research were identified as priority areas for cooperation during a workshop held 19 May 2020 under the umbrella International Coalition of Medicines Regulat...
  • Regulatory NewsRegulatory News

    EMA Lays Out Plans for Testing for Nitrosamine Impurities

    As potentially cancer-causing impurities have been identified in some blood pressure and heartburn medicines, the European Medicines Agency (EMA) is outlining a three-step process whereby manufacturers can identify and control nitrosamine impurities, including N-nitrosodimethylamine (NDMA). EMA on Monday released new templates for manufacturers to complete as part of their risk evaluations and confirmatory testing. By 26 April 2020, EMA is calling on companies to conduc...
  • 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

    EMA to Cease Printing and Dispatching of CPPs During Relocation to Permanent Building

    As the European Medicines Agency (EMA) relocates within Amsterdam, the agency said on Tuesday that it will temporarily cease its printing and dispatching of Certificates of Pharmaceutical Products (CPPs) from 13 December until 18 January 2020. CPPs confirm the marketing authorization status of products authorized through the centralized procedure and they confirm compliance with good manufacturing practices. The temporary halt is occurring because of the agency’s rel...