Pharma GMP News of the Week March 05, 2023

Pharma GMP News of the Week: 5-March-2023

Period: February 26, 2023 to March 4, 2023

News from EDQM “The future of pyrogenicity testing: new approaches discussed at joint EDQM-EPAA event”

Date of news: February 27, 2023

For certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal product(s)), the European Medicines Agency (EMA) has started a pilot programme to provide scientific advice on the intended clinical development strategy and proposals for clinical investigation. Manufacturers can now submit a letter of interest to take part in a pilot project involving scientific guidance from panels of experts in medical devices. 

To read in detail, refer to the following link.

Source: The future of pyrogenicity testing: new approaches discussed at joint EDQM-EPAA event 

News from EMA “Agency pilots scientific advice for certain high-risk medical devices”

Date of news: February 27, 2023

For certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal product(s)), the European Medicines Agency (EMA) has started a pilot programme to provide scientific advice on the intended clinical development strategy and proposals for clinical investigation. Manufacturers can now submit a letter of interest to take part in a pilot project involving scientific guidance from panels of experts in medical devices.

Source: EMA pilots scientific advice for certain high-risk medical devices | European Medicines Agency

News from European Commission “political agreement in principle on the Windsor Framework, a new way forward for the Protocol on Ireland / Northern Ireland”

Date of news: February 27, 2023

According to modifications to the Brexit deal reached by the UK and the EU, the UK Medicines and Healthcare products Regulatory Agency (MRHA) is now in charge of regulating human medicines in Northern Ireland.

Source: 

  1. Questions and Answers: political agreement in principle on the Windsor Framework, a new way forwardfor the Protocol on Ireland / Northern Ireland
  2. https://www.gov.uk/government/news/windsor-framework-unveiled-to-fix-problems-of-the-northern-ireland-protocol  

News from EDQM “Pharmacopoeial Discussion Group achievements: sign-off on harmonisation texts”

Date of news: February 27, 2023

The Pharmacopoeial Discussion Group (PDG), as stated in the press release on January 6, 2023, met for its yearly autumn conference from October 18–21, 2022. The World Health Organization (WHO) was present as an observer, along with the three founding members of the PDG—the European Pharmacopoeia (Ph. Eur. ), the Japanese Pharmacopoeia (JP), and the United States Pharmacopoeia (USP)—as well as the Indian Pharmacopoeia Commission (IPC), which was a participant in the PDG pilot for international expansion.

See the press release titled “Pharmacopoeial Discussion Group achievements: sign-off on harmonisation texts” for complete information regarding the individual work programme sign-offs.

Source: https://www.edqm.eu/en/-/pharmacopoeial-discussion-group-achievements-sign-off-on-harmonisation-texts 

MHRA has announced Graduate Scheme on its website

Date of news: February 28, 2023

The three-year MHRA Graduate Programme is a graduate development programme that offers an exciting chance to make a significant contribution to patient safety and public health protection. You would contribute to:

– Facilitating the rapid and flexible development of medical products in support of the government’s objective for life sciences innovation.

– Critically evaluating the advantages and disadvantages of drugs and medical devices in order to make wise choices on the standard and accessibility of healthcare.

– Making use of effective vigilance procedures that may promptly identify, track, and assess any negative effects and issues relating to medications and medical equipment.

Source: MHRA Graduate Scheme – GOV.UK 

FDA published “Q13 Continuous Manufacturing of Drug Substances and Drug Products”

Date of news: March 1, 2023

This recommendation outlines scientific and legal factors to take into account when developing, implementing, running, and managing the lifecycle of continuous manufacturing. In addition to providing clarification on CM principles, this guideline outlines scientific techniques and regulatory considerations unique to CM of drug substances and drug products, building on earlier International Council for Harmonization (ICH) Quality guidances.

Source: https://www.fda.gov/media/165775/download 

FDA published draft guidance “Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens”

Date of news: March 1, 2023

In order to help sponsors create monoclonal antibodies (mAbs) and other therapeutic proteins that directly target viral proteins or host cell proteins driving pathogenic mechanisms of infection, this guidance is intended to offer suggestions. The creation and implementation of a potency assay (or assays) sufficient to verify that each lot is generated consistently with the potency required to achieve clinical efficacy and that such potency is maintained over the product’s shelf life is a crucial quality control measure for these products. With the aim of assisting in ensuring that medication developers provide appropriate information to assess potency at each step of a product’s life cycle, this guidance offers specific recommendations to drug developers.

Source: https://www.fda.gov/media/165746/download 

News from EDQM “European Pharmacopoeia Commission creates new Excipients Strategy Working Party”

Date of news: March 1, 2023

The development of a new Excipients Strategy Working Party (EXS) was authorised by the European Pharmacopoeia Commission (EPC) during its 173rd session in June 2022 (see “Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022”). The European Pharmacopoeia (Ph. Eur.) excipient strategy will be further developed by the EXS Working Party, which will continue to address the specifics of these significant pharmaceutical constituents in Ph. Eur. monographs.

Source: https://www.edqm.eu/en/-/european-pharmacopoeia-commission-creates-new-excipients-strategy-working-party  

MHRA published “Response template for applicants”

Date of news: March 3, 2023

The applicant should prepare the answers to the MHRA questions by compiling them verbatim into this response template, just as they have been introduced in the Request for Further Information (RFI) or the Commission on Human Medicines (CHM) Letter.

There should be as many copies of each component (question, applicant response, and assessor remark box) as there are questions under each pertinent subject. Even if they are on the list of questions, ASMF-related inquiries need to be addressed separately using this response template.

Source: Response template for applicants – GOV.UK

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