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Consultation outcome: Strategy for pharmacopoeial public quality standards for biological medicines

Medicines Healthcare Products Regulatory Agency

September 16
13:50 2019

Consultation response: Strategy for pharmacopoeial public quality standards for biological medicines

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If you use assistive technology (such as a screen reader) and need aversion of this document in a more accessible format, please email webupdates@mhra.gov.uk.Please tell us what format you need. It will help us if you say what assistive technology you use.

Detail of outcome

Biological medicines are an increasingly important part of healthcare worldwide. Their quality is assured by a regulatory framework which includes compliance to public quality standards. Both documentary and physical standards work together to ensure that biological medicines are of acceptable quality for use by the patient.

In the UK, documentary standards exist as texts published in the British Pharmacopoeia. The Agency has developed a strategy for the creation of pharmacopoeial public quality standards for biological medicines.

In January 2017 a public consultation on this strategy was published, which closed 10th April 2017. The document attached document provides the Agencys official response to the replies received.

Any questions related to this strategy can be directed to BiolStandards@mhra.gov.uk.

Original consultation

Summary

We are developing a strategy for the creation of pharmacopoeial public quality standards for biological medicines. We would like your input regarding how they are used & can be improved as well as feedback on our draft strategy.

This consultation ran from
to

Consultation description

Biological medicines are an increasingly important part of healthcare worldwide. Their quality is assured by a regulatory framework which includes compliance to public quality standards. Both documentary and physical standards work together to ensure that biological medicines are of acceptable quality for use by the patient.

In the UK, documentary standards exist as texts published in the British Pharmacopoeia. The Medicines and Healthcare products Regulatory Agency is developing a strategy for the creation of pharmacopoeial public quality standards for biological medicines. This public consultation seeks input from stakeholders regarding how they are used and can be improved as well as feedback on the Agencys draft strategy.

You can respond to this consultation by using the form in the consultation document, or by downloading the Microsoft Word version above. Responses should be sent to BiolStandards@mhra.gov.uk by 10 April 2017.

In this document there is:

  • an introduction
  • a draft pharmacopoeial biological standards strategy
  • a response form

Documents

Biological Standards Consultation Document

This file may not be suitable for users of assistive technology. Request an accessible format.

If you use assistive technology (such as a screen reader) and need aversion of this document in a more accessible format, please email webupdates@mhra.gov.uk.Please tell us what format you need. It will help us if you say what assistive technology you use.

Biological Standards Consultation response document

This file may not be suitable for users of assistive technology.

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