Overview
Welcome to Issue #4 of Regulatory Pulse: Pharma and Medical Devices Newsletter.
This newsletter is a monthly source for the latest updates and insights on regulatory developments in the pharmaceutical and medical device industries. It provides comprehensive coverage of new regulations, guidelines and compliance requirements from EU regulatory bodies and other key agencies.
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New Guidance Concerning Radiopharmaceuticals Supply Chain
The European Medicines Agency and the Heads of Medicines Agencies (HMA) have published Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address vulnerabilities in the supply chain of radiopharmaceuticals. The Recommendations concern occasional shortages of radiopharmaceuticals that have arisen throughout the EU as a result of disparity between manufacturing capacity and demand. Shortages are often due to dependency on third countries for the enrichment of stable isotopes and key source materials as well as limited manufacturing capacity at aging research reactors in the EU. The Recommendations advise EU Member States to establish policy measures to support security and continuity of supply of medical radioisotopes in the EU/EEA for the manufacturing of radiopharmaceuticals, including through prioritization of domestic capabilities to reduce dependency on third country sources and to address the limited manufacturing capacity in the EU. They also underline the need for the European Commission to increase domestic capabilities in the EU, and improve infrastructure and production facilities, such as nuclear reactors.
New Manufacturer’s Incident Report PMSV reporting forms - European Commission
The European Commission has published a new reporting template for Manufacturer Incident Reports (MIR) for Serious Incidents (SI). The template will become obligatory in November 2025. Many of the changes to the existing template are small, such as changes in wording. However, there are a few substantive changes – including a requirement to specify both the date on which the manufacturer became aware of an incident and the date on which the incident was reported. There is also now a clear requirement to state whether there is a suspected or confirmed relationship between the incident and the device. An MIR guidance document has been published with the new template.
Medical Device Post-Market Surveillance Activities in GB (Medical devices: post-market surveillance)
The UK authorities have published guidance concerning the implementation of post-marketing surveillance obligations in relation to medical devices in Great Britain. The regulatory obligations will begin to apply from 16 June 2025. The new guidance applies to four main areas: guidance on implementation of the Regulations; supplementary guidance concerning manufacturers’ vigilance system; periodic safety update reports; and device-specific vigilance.
Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks
Following publication of a report by the European Federation of Pharmaceutical Industry Associations (EFPIA) in which EFPIA concluded that the EU was becoming a less attractive location for conducting clinical research, the European Commission has told the Pink Sheet that it had heard the concerns raised by stakeholders regarding bottlenecks and regulatory insufficiencies that contribute to a decline in the number of clinical trials conducted in Europe. In its response, the European Commission mentions a number of proposed actions. However, it is unclear how far the actions proposed will address these concerns.
Council of Ministers Agrees its Position for Negotiation of the Pharma Package with the European Parliament
Having agreed its position on the European Commission’s proposal for new legislation governing the regulation of medicinal products, the Council of Ministers has declared that it is ready to begin negotiations with the European Parliament. The Council’s mandate for negotiations introduces several key amendments to the proposed legislation. These include a proposal that companies that produce innovative medicines be able to prevent competitors from accessing data used to develop those medicines for eight years and the right of producers of innovative medicines to benefit from one year of regulatory market protection, extendable to two years, if certain pre-defined key objectives are achieved. The Council has also proposed an addition to the Community Code on medicinal products (Directive 2001/83/EC) that would provide EU Member States with power to require marketing authorization holders for medicinal products to make the product available in sufficient quantities to cover the needs of patients in the territory.
