Pharma GMP News of the Week: 4-September-2022

Period: August 28, 2022 to September 3, 2022

News from TGA – Update to the Manufacturing Principles for medicines, APIs & sunscreens

Date of news: August 25, 2022

The Therapeutic Goods Administration (TGA) in Australia has provided information on the modifications brought about by the adoption of version 15 of the PIC/S Guide to GMP for Medicinal Products.

The objective of this adoption is, the TGA constantly updates and adopts the GMP guidance to:

  • Give direction for the control of emerging technology;
  • Fill up any gaps in the present compliance standards;
  • Control risks discovered by legislation and inspections;
  • Encourage ongoing developments in the production of medications.

Source: https://www.tga.gov.au/news/notices/update-manufacturing-principles-medicines-apis-sunscreens-0 

The MDCG promotes hybrid audits. After hearing concerns from a variety of stakeholders on the lack of notified body capacity, the MDCG produced a position paper

Date of news: August 26, 2022

Following input from numerous stakeholders about their worries regarding the lack of notified body capacity, the MDCG produced a position paper on August 26. The organisation released a position paper with 19 points that it believes will help the issue.

Source: https://health.ec.europa.eu/system/files/2022-08/mdcg_2022-14_en.pdf 

MHRA seeks Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees

Date of news: August 31, 2022

This consultation’s goal is to gather input from interested parties on proposed changes to the Medicines and Healthcare Products Regulatory Agency’s statutory fees (MHRA). Three categories can be used to group the suggested changes:

  • A 10% increase in indexation for all statutory fees
  • 61 substantially underrecovering fees will receive a further increase in order to achieve cost recovery.
  • Since the recent price revisions in 2016/2017 for medications and 2017/2018 for medical devices, there have been the introduction of 22 new fees for services that need cost-recovery.

The fee proposals outlined in this consultation aim to achieve full cost recovery in accordance with HM Treasury’s principles on Managing Public Money and ensure that the MHRA has the resources necessary to deliver the high-quality service that patients, the general public, and industry want and expect.

Source: https://www.gov.uk/government/consultations/consultation-on-proposals-for-changes-to-the-medicines-and-healthcare-products-regulatory-agencys-statutory-fees

Health Canada has adopted updated Guidance on nitrosamine impurities in medications from September 1, 2022

Date of news: September 1, 2022

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities/medications-guidance.html 

News from MHRA “Canada – United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices”

Date of news: September 1, 2022

Health Canada, the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the Veterinary Medicines Directorate (VMD) have agreed to broaden the current method of recognising GMP inspection results so as to include inspections conducted in nations outside of the respective Parties’ jurisdictions (i.e. extra-jurisdictional inspections) for human and veterinary finished products included in the operational scope of Annex 1 of the Protocol for pharmaceuticals.

Source: https://www.gov.uk/government/publications/canada-united-kingdom-trade-continuity-agreement-protocol-for-recognition-of-good-manufacturing-practices/canada-united-kingdom-trade-continuity-agreement-protocol-for-recognition-of-good-manufacturing-practices

The 11th Edition of the European Pharmacopoeia has a new general chapter on the implementation of pharmacopoeial procedures.

Date of news: September 6, 2022

The requirement more concisely stated in the Ph. Eur. General Notices is elaborated upon in this revised general text, which states that “when implementing a Ph. Eur. analytical procedure, the user must assess whether and to what extent its suitability under the actual conditions of use needs to be demonstrated according to relevant monographs, general chapters and quality systems”.

A significant addition to the Ph. Eur. is the chapter Implementation of Pharmacopoeial Procedures (5.26), which offers more thorough information on one of the crucial procedures underlying the proper application of Ph. Eur. monographs.

Source: https://www.edqm.eu/en/-/new-general-chapter-on-implementation-of-pharmacopoeial-procedures-published-in-the-11th-edition-of-the-european-pharmacopoeia

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