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  • 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...
  • Regulatory NewsRegulatory News

    EMA’s CHMP Recommends First Ebola Vaccine, 6 Other Medicines

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced recommendations for seven new medicines for approval, including a conditional marketing authorization for Merck’s Ebola vaccine Ervebo (rVSVΔG-ZEBOV-GP, live), which is the first vaccine for those 18 years and older at risk of infection with the Ebola virus. EMA said that preliminary data suggest the vaccine is effective in the current Ebola outbreak in the De...
  • 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.   ...
  • Regulatory NewsRegulatory News

    EC Offers New Site Suitability Template Under Incoming Clinical Trial Regulation

    The European Commission (EC) on Tuesday published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which has yet to take effect. The template was developed and endorsed by the EU Clinical Trials Expert Group on 9 October to comply with the new regulation, known as Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use. “However, this templat...
  • 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...
  • ReconRecon

    Recon: Novartis Wins FDA Approval for Eye Drug; New ICER Report on Net Drug Price Hikes

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis gets FDA boost in crowded eye drug market ( Reuters ) ( PMLive ) ( Press ) ICER Identifies Costliest US Drug-Price Hikes That Are Not Supported by New Clinical Evidence ( ICER ) ( Reuters ) ( Stat -$) Continuing Appropriations Act Changes Treatment of Authorized Generics in Medicaid Rebate Average Manufacturer Price ( FDA Law Blog ) FDA leaders worry ...
  • Regulatory NewsRegulatory News

    EMA Staff Losses Tick Up as Workload Increases

    As the interim arrangements to allow European Medicines Agency (EMA) staff to telework from London have now ended, the agency said its total available workforce in Amsterdam is about 730, which is about 20% less than the 900 staffers EMA had in London. “Due to these ongoing resource constraints, delivery of EMA’s work programme for Q4 2019 will be challenging for the Agency, particularly in view of the need to implement new legislation for veterinary medicines and medic...
  • Regulatory NewsRegulatory News

    When Can RWE Translate Into Credible Evidence? EMA Officials Discuss

    Real-world evidence (RWE) may provide an opportunity to learn more about a drug’s benefits and risks, but officials from the European Medicines Agency (EMA) said in an article published Tuesday in Clinical Pharmacology & Therapeutics that there will need to be adequate statistical methods to extract, analyze and interpret RWE before they can translate into credible evidence. In order to ensure that any new analytical methods are acceptable for regulators, the EMA auth...
  • Regulatory NewsRegulatory News

    3D Bio-Printed Products: ICMRA Members Discuss Potential Regulatory Frameworks

    As part of a project on emerging technologies, six regulators involved in the International Coalition of Medicines Regulatory Authorities (ICMRA) recently published a case study delving into the challenges of regulating 3D bio-printed products. In this hypothetical case, the regulators evaluated 3D bio-printed knee meniscus tissue and discussed how they would tackle similar products. The case study was conducted by Australia’s Therapeutic Goods Administration (TGA), Bra...
  • Regulatory NewsRegulatory News

    Patient-Focused Drug Development: New FDA Draft Guidance Delves Into What’s Important

    The US Food and Drug Administration (FDA) on Monday published the second in a series of four guidance documents on patient-focused drug development, with this latest draft helping sponsors identify what is most important to patients with respect to their experience with disease burden and treatment. In determining what’s important, FDA recommends that sponsors use qualitative research methods, which can generate in-depth thoughts from patients in their own words through...