• Regulatory NewsRegulatory News

    EMA preps for EU common standard on electronic product information

    The European Medicines Agency (EMA) this week launched a stakeholder consultation on a draft EU common standard for electronic product information (ePI) for human medicines.   The common standard would provide a semi-structured template for ePI incorporating the authorized, statutory product information for medicines, including the summary of product characteristics (SmPC), labeling and package leaflet. EMA says that ePI will be better suited “for electronic handling a...
  • Regulatory NewsRegulatory News

    Demand forecasting in a pandemic: New considerations from EMA

    A new reflection paper from an EU steering group on drug shortages provides considerations for forecasting demand for medicines in the face of global health emergencies.   “The methodology is based on pragmatic predictions of demand for certain medicines and encourages the use of the best available information, with an aim to reach the right balance between existing uncertainties with regards to the actual future demand, and the imperative public health need to prepare...
  • RoundupsRoundups

    Euro Roundup: Switzerland moves to mitigate split from EU on device regulation

    Switzerland has adopted supplemental provisions to its new Medical Devices Ordinance (MedDO) to soften the impact of its split from the European Union. The action comes as the failure to update a mutual recognition agreement (MRA) erects barriers to trade between Switzerland and the EU.   Swiss medical device manufacturers have enjoyed barrier-free access to the EU single market since 2001. However, the EU refused to consider updating the MRA in light of the new EU ...
  • Regulatory NewsRegulatory News

    Industry and patient groups call for IVDR delay

    In the wake of the 26 May EU implementation of the new medical device Regulation (MDR), a trade group, a patient association and a data analytics firm have jointly called for a delay in implementation of the parallel In Vitro Diagnostics Regulation (IVDR), now slated for 26 May 2022. Without a course correction, the organizations cite the potential for serious disruptions in patient care, especially in targeted therapies for cancer patients.   With just a year to go ...
  • Regulatory NewsRegulatory News

    ATMP trade organizations call for GMO exemption in EU

    In a joint paper and press release, major trade associations for cell and gene therapy developers are calling for relaxation of EU regulations that treat these advanced therapies as genetically modified organisms (GMOs).   The Alliance for Regenerative Medicine (ARM), European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Association of Bioindustries (EuropaBio) joined in the 24 May publication of the paper in Human Gene Therapy,...
  • ReconRecon

    Recon: CMS head confirmed; EU seeks breach-of-contract fine from AZ

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden's CMS head confirmed, but FDA pick remains elusive ( Axios/Yahoo ) BARDA Funding Freeze Risks Companies Abandoning COVID Therapeutic Work ( Pink Sheet ) CDC: Half of US adults now vaccinated against COVID-19 ( The Hill ) Pandemic creates 500-site backlog for FDA, despite decade of dwindling US inspections ( Pharma Tech ) The Vaccine Rollout Is Changing ...
  • ReconRecon

    Recon: ASCO 21 updates; Moderna goes for teen EUA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says that its vaccine is effective for 12- to 17-year-olds and that it will seek F.D.A. authorization ( NYT ) ( NPR ) President Biden still hasn’t appointed a permanent FDA commissioner. That has big implications for upcoming drug approvals ( Fortune ) Bipartisan Legislation Introduced to Advance Biomedical Research Stalled by Pandemic ( Global Genes ) ...
  • Regulatory NewsRegulatory News

    EMA recommends bluebird bio's Skysona, seven other medicines

    The European Medicines Agency (EMA) issued a favorable opinion for bluebird bio’s Skysona (elivaldogene autotemcel), a gene therapy that treats early cerebral adrenoleukodystrophy (CALD). Seven other medicines also received positive recommendations from the agency’s Committee for Medicinal Products for Human Use (CHMP) during its May meeting.   Skysona’s status as an advanced therapy medicinal product (ATMP) means it was first assessed by EMA’s Committee for Advanced T...
  • ReconRecon

    Recon: NGM's NASH drug fails; Alzheimer's breakthrough?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. Covid cases hit lowest level since June ( CNBC ) ( NPR ) Scott Gottlieb says vaccinations are not the only factor driving U.S. Covid cases down ( CNBC ) Passing the Buck: What the CDC Guidance on Masks Gets Wrong About Public Health (Harvard Law blog ) Covid vaccine passports: Everything we know so far ( CNBC ) White House says no plans to require vacci...
  • RoundupsRoundups

    Euro Roundup: Northern Ireland warns of Brexit border strain for pharmaceuticals

    The Minister for Health in Northern Ireland has warned “additional bureaucracy and management” created by Brexit is putting a strain on a team that advises on medicines and pharmaceutical issues.   Robin Swann, the politician in charge of health in Northern Ireland, framed the problem as a result of the solution Brexit negotiators came up with to avoid the creation of a hard border on the island of Ireland. The solution, the Northern Ireland Protocol, leaves the jurisd...
  • RoundupsRoundups

    Euro Roundup: EMA streamlines processes to handle COVID-19 volume

    The European Medicines Agency (EMA) is temporarily revising its processes to cope with a rising volume of work related to the COVID-19 pandemic. EMA made the changes to ensure it can handle a “very active pipeline” that is expected to yield up to five COVID-19 therapies this year.   Faced with that workload, EMA is temporarily freeing co-rapporteurs from the need to provide their own assessment reports on initial marketing authorization applications for non-COVID-19 ...
  • Regulatory NewsRegulatory News

    Euro Convergence: EU pediatric medicines regulatory framework needs simplification, optimization

    Industry would like to see some “pragmatic” changes to the regulatory process for pediatric medicines in the EU, according to a recent presentation at RAPS Euro Convergence 2021.   These changes include incorporating scientific discussion throughout a product’s life cycle, comparable reporting requirements for pediatric trials to those for adult trials, and optimization and simplification of pediatric investigation plan (PIP) procedures and compliance checks, said Thom...