Since adoption of the Strategy for Pharmacopoeial Public Quality Standards for Biological Medicines in 2017, the quality of biological medicinal products has received a major boost. The 2017 Strategy was developed as a result of the increasing importance of biological medicines to global healthcare strategies and the important role of standards in the assurance of quality and enabling of innovation. This month, the MHRA published an Update on progress made since the publication of the Strategy. The Update focuses on the following aspects:

  • The importance of quality, innovation and life sciences and the foundational position of standards in supporting innovation.
  • The progress made implementing the strategy in terms of standards development, innovative product development and customer and stakeholder engagements.
  • Special focus is placed on biotechnologically produced proteins and advanced therapy medicinal products (ATMPs). The Update acknowledges that biotechnologically produced proteins are an increasingly important part of healthcare strategies worldwide and announces that a working party has been formed since the publication of the Strategy to explore these concepts. In the area of ATMPs, the importance of engaging and developing networks with stakeholders is well recognised and a working party comprised of external and internal experts is to be established over the next 12 months.

The Update also offers a forward look to the next 12 months to continue to support the implementation of the strategy with a continued focus on standards development, engaging customers and stakeholders and collaboration with international peers. The 2019 Public Update can be found here. The 2017 Strategy can be found here.