Standards for biological medicines - understanding them and how they make a difference

The quality of biological medicines is assured by biological standards held by the British Pharmacopoeia (BP) and the National Institute for Biological Standards and Control (NIBSC)

13th January 2017

Recently published MHRA news story regarding biological medicines states:

"Biological medicines are an increasingly important part of healthcare. Our role as medicines regulator is to make sure the medicines you and your family take are of an acceptable quality. This quality is assured by a regulatory framework which includes compliance to public standards. We have launched a consultation which will look at both how we can best ensure the quality of medicines using standards and how standards can act as enablers for innovation now and in the future."

The news story covers answers to the following important questions -

  • What is a biological medicine?

  • Why are biological medicines important?

  • What are biological standards?

  • Who uses standards?

  • Why are standards needed?

  • Can standards enable innovation?

  • What is the future for biological standards?

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