GMP Update: Consequences from the New EU Commission Proposal

Recommendation

7/8 May 2024

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On 26 April 2023 the European Commission published the proposal for the envisaged revision of the EU pharmaceutical legislation. The changes are to be regulated in a directive and a regulation.

Specifically, Directive 2001/83 (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use) and Directive 2009/35/EC are to be replaced. The proposal for a new Regulation 726/2004 (authorisation of medicinal products and establishment of the European Medicines Agency) is intended to replace Regulation 141/2000 for orphan drugs and Regulation 1901/2006 for paediatric medicinal products, but also brings a number of new and adapted regulations.

The European Commission's proposal aims to make EU pharmaceutical legislation more agile, flexible and adaptable to the needs of patients and businesses in the EU. The reform aims to improve the availability, accessibility and affordability of medicines, while promoting higher environmental standards and increasing the competitiveness and attractiveness of the pharmaceutical industry in the EU. Key elements of the proposal include reducing administrative burdens, promoting innovation and competitiveness, addressing pharmaceutical shortages, ensuring environmental sustainability and tackling antimicrobial resistance. A minimum period of eight years for the regulatory protection of innovative medicines is proposed, which can be extended on the basis of certain criteria. In addition, the fight against antimicrobial resistance (AMR) is supported, as it is considered one of the major health threats in the EU.

Planned amendments with GMP relevance

An important change with GMP relevance are the adapted requirements for the qualification of the Qualified Person (QP), which are so far regulated in Article 48 of Directive 2001/83/EU. These are now defined in an annex to Directive 2023/132 (Annex III).

Relief with regard to the "Written Confirmation": Member States may waive the requirement of the "Written Confirmation" within the scope of the period of validity of the GMP certificate (Art. 158 of Directive 2023/132).

Remote inspections: Facilitation for inspectorates regarding remote inspections and risk-based approaches to inspection frequency.

Another focus is on the security of supply of medicinal products. This is to be regulated in the new Regulation (Art. 116 ff): The proposal contains provisions for the monitoring and management of shortages and critical shortages of medicinal products. Marketing authorisation holders are obliged to inform the competent authority of a Member State where the medicinal product is placed on the market and the EMA of any permanent or temporary cessation or suspension of the marketing or supply of the medicinal product. They must also draw up a plan to prevent supply shortages. The competent authority and EMA shall monitor any potential or actual shortage of medicinal products and the competent authority may request additional information from the marketing authorisation holder, such as a plan to limit the shortage or a risk assessment. The marketing authorisation holder must submit the requested information without delay.

Other interesting points of the regulation

• Definitions of "critical medicinal product", "shortage of supply", "critical shortage of supply" and "critical shortage of supply in a Member State" (Art. 2),
• Regulations on AMR (antimicrobial resistance) including an "exclusivity voucher".

The Directive contains new passages on the following topics, among others

• New regulations on regulatory data protection (RDP),
• Repurposing: a so-called protection period for medicinal products with a new therapeutic indication,
• "Bolar exception": Extension of the so-called Bolar rule, according to which certain studies and trials are not considered to infringe the patent or supplementary protection certificate,
• Rewards for paediatric medicines,
• Adjustments to risk management plans for the authorisation of generic medicines and biosimilars,
• Electronic product information (ePI) (as opposed to paper leaflets),
• Regulations for products combining a medicinal product and a medical device,
• Evaluation of certain excipients (colours as authorised food additives).

Q&A document

The EU Commission has also directly published a Q&A document (Frequently Asked Questions: Revision of the Pharmaceutical legislation), which describes well the background and objectives. Better than the actual press release does.