Changes ahead for EU pharmacovigilance and authorisation requirements

This article was co-authored by Natalie Man, Litigation Assistant, London.

Recently, there have been considerable developments in respect of the EU’s product safety regulatory regime for pharmaceuticals, reflected in a recent consultation on key EU legislation on pharmacovigilance (activities relating to the detection, assessment and prevention of adverse effects of medicines/vaccines) and a report produced by the European Commission on the efficacy of an EU regulation that controls the sale and safety monitoring of medicines.

These developments will have a significant impact on all key stakeholders involved in the pharmaceutical industry, particularly those that will need to implement changes to ensure that products they produce and/or sell are adequate for the market.

European Commission seeks views on pharmacovigilance activities

The Commission Implementing Regulation (EU) 520/2012 (the Regulation) has formed the basis of a targeted consultation conducted by the European Commission, which has recently completed its initial stage to collect stakeholder’s opinions. The consultation focuses on the operation and performance of pharmacovigilance activities provided for in Regulation (EC) 726/2004 and the Council and Directive 2001/83/EC of the European Parliament.

These laws set out procedures and authorisation requirements for medicinal products for human use in the EU.

The Directive also forms part of the key human medicines regime in the EU, which is aimed at ensuring a high level of protection of public health.

The consultation gave stakeholders involved in pharmacovigilance activities until the 15 October 2021 to share their views on proposed amendments. Overall, since the implementation of the Regulation back in 2012, it has been considered as satisfactory, according to the consultation proposal document. However the amendments will look to improve the following topics in light of new technical standards:

  • The matter of the Pharmacovigilance System Master File
  • The minimum requirements for the monitoring of data in the Eudravigilance database
  • The use of pharmacovigilance terminology, formats and standards
  • The transmission of information pertaining to suspected adverse reactions
  • Post-authorisation safety studies.

While these areas formed the main focus of the consultation, stakeholders were also encouraged to suggest any improvements or proposals regarding the Regulation more generally.

European Commission’s 10 yearly report on medicinal products for human use

It is obligatory for the Commission to publish a report at least every 10 years detailing the experience it has acquired from operating the procedures for medicinal products for human use. Regulation (EC) No 726/2004 and Chapter 4 of Title III of Directive 2001/83/EC set out these procedures which are applicable to the authorisation, supervision and pharmacovigilance of medicinal products, for human and veterinary use. The EC’s most recent report was published earlier this year and has highlighted areas for improvement with respect to the authorisation system for medicines. However, it is too soon for the effects of the report’s findings to be felt by the industry as businesses try to amend their processes to become more efficient. The full practical impact of the report’s discoveries remain to be seen.

There are many different protocols in the EU that can be carried out to grant a marketing authorisation for medicinal products. However, the report specifically covers the EC’s role within the centralised, decentralised and mutual recognition procedures.

The report incorporates analysis from an external contractor’s study that was circulated to Member States, the European Medicines Agency (EMA) and the Coordination Group for the Mutual Recognition and Decentralised Procedures – human (CMDh), which focused on the effectiveness and efficiency of the system. Generally, the data provided by the contractor’s study demonstrated that currently the system of EU procedures for marketing authorisation and monitoring of medicinal products for human use “meets the objectives laid down in the legislation”.

Effectiveness of the system

  • Achieved its specified legislative objectives e.g. regulatory initiatives leading to greater harmonisation between Members States and the 2012 pharmacovigilance legislation.
  • New challenges were presented by increased level of activity and rapid scientific developments.

Efficiency of the system

Areas for improvement:

  • The system’s capability to deal with emergencies and shortages, which existed prior to the COVID-19 pandemic.
  • The amendments submission process and the application procedure for small and medium-sized enterprises.

Whilst the report demonstrates that the system broadly meets its objective of completing the internal market in pharmaceutical products and creates a regulatory framework that supports the competitiveness of the European pharmaceutical sector, rapid scientific developments continue to challenge the system. Proposed solutions to these challenges will be incorporated into the Pharmaceutical Strategy for Europe.

Impact on companies in relevant industries and practical next steps

It remains to be seen whether the improvements identified through the consultation on the operation of pharmacovigilance activities and in the report on the procedures set out in Regulation (EC) No 726/2004 will have a practical impact on key stakeholders moving forward. Nonetheless, the consultation process to allow stakeholders to contribute their views is invaluable and changes in these topic areas should be monitored closely.

All stakeholders in the pharmaceutical industries should follow these initiatives closely to consider and proactively adapt to any trends developing in that regard. Some practical steps companies may wish to take at this juncture, include:

  • Support by the EC via the promotion of research and technology, businesses should look for ways to ensure their products are more sustainable to coincide with the aims of the Pharmaceutical Strategy for Europe.
  • Assess manufacturing processes to ensure they are of the highest quality and meet required standards.
  • Ensure communications with regulatory authorities are maintained so that regulatory cooperation and exchange of information with international regulators can be easily carried out.

Streamline procedures to reduce administrative burdens in order to use more resources and time on innovation.

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