EU: In addition to the entry into force of previously prepared parts of legislation in the field of medicines, 2022 is marked by preparations for changes to the general regulations in the field of medicines

On 28 January 2022 new legislation in the field of veterinary medicines, entered into force, which aims to adapt regulations to current challenges, promoting innovation and accessibility of medicines, and stepping up EU efforts to combat AMR.

On 31 January 2022, Regulation on Clinical Trials of Medicinal Products no. 536/2014 (CTR), which is significantly delayed mainly due to waiting for the full functionality of the information system (CTIS / Clinical Trial Information System) with a centralized EU portal and database on clinical trials in the EU, which allows streamlining the reporting, evaluation, and monitoring of clinical trials in EU. Regulation no. 536/2014 repeals the current Clinical Trials Directive no. 2001/20 / EC, although transitional periods are foreseen for ongoing tests and those to be notified by the end of January 2023.

A proposal for a revision of pharmaceutical legislation is being prepared and will be available by the end of 2022, including a proposal for a revision of Directive 2001/83 / EC and Regulation (EC) No 726/2004. In 2020, the European Commission published a European Strategy for Medicines, emphasizing the importance of medicines for public health, in particular meeting unmet health needs and access to medicines, promoting industry competitiveness and innovation, strengthening the supply chain, strategic EU autonomy and preparedness. and crisis response. At the same time, he sees his enhanced role in guiding and creating global trends through cooperation and the application of common standards. The response of participants in the system was verified by sending a questionnaire answered by manufacturers, distributors, academia, doctors, pharmacists, patients… In February 2022, the Commission published a Synthesis Report and responses to a public consultation on the revision of general pharmaceutical legislation, which will affect the expected final audit proposal.

Do you need additional knowledge or assistance in meeting the requirements of pharmaceutical legislation?

With the help of our educations and consulting services, we can help you meet the regulatory requirements in the field of medicines:

• Regulatory seminars for individual pharmaceutical companies

  • Complete regulation of medicines (for new employees or those in need of refreshment or deepening of knowledge)
  • Selected areas of drug regulation (topics and target groups by agreement)

• Regulatory / professional advice in the field of medicines (expert opinions, strategies,

               dossier evaluation, outsourcing…


Regulation on veterinary medicinal products (VMPs)

Regulation on veterinary medicinal products (VMPs)