Public quality standards for biological medicines

Public quality standards for biological medicines

Medicine quality is receiving a major boost with the implementation of activities surrounding the Medicine and Healthcare products Regulatory Agency’s Strategy for Pharmacopoeial Public Quality Standards for Biological Medicines.

In October 2017, the Agency adopted the strategy in response to extensive feedback received through a public consultation, which was opened in January of the same year.

The quality of biological medicines is an increasingly important part of healthcare worldwide and is critical to delivering effective public health. These standards, regulated by the Agency, help make sure biological medicines are of acceptable quality for use by patients.

The Public update: 2019 looks at:

  • 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, customer and stakeholder engagements.
  • The next 12 months with a continued focus on standards development, engaging customers and stakeholders and collaboration with international peers.

The strategy recognises the importance of standards and the huge value they bring to the quality of innovative products.

Collaboration has been key to the progression of the strategy, bringing together all arms of the Agency, while reaching out to the BioIndustry Association, the Cell and Gene Therapy Catapult, broader pharmaceutical industry, regulators and pharmacopoeias globally.

Customers, partners and stakeholders can find out more about the development and implementation of the strategy by emailing