Pharma GMP News of the Week: 16-October-2022

Period: October 9, 2022 to October 15, 2022

News from EMA – In the EU, the EMA and the HMA are moving ahead with plans to extend access and improve the quality of data used to inform decisions on the benefits and hazards of medicines

Date of news: October 10, 2022

The EMA-HMA Big Data Steering Group has endorsed two documents for public consultation, one looking at the quality of all data types used in regulatory decision-making and the other concentrating primarily on the discoverability of real-world data.

Data quality is essential for realising the full potential of data-driven regulation and fostering patient and healthcare professional confidence. The proposed Data Quality Framework for EU Medicine Regulation, which is now available for public comment, establishes quality criteria for data used in medicine regulation to ensure they are fit for purpose to support benefit-risk determinations.

Source: High-quality data to empower data-driven medicines regulation in the European Union 

The EMA published a data quality framework in order to get stakeholders on the same page when it comes to data quality

Date of news: October 10, 2022

This framework covers broad data quality concerns essential for regulatory decision making, definitions for data dimensions and sub-dimensions, as well as characterization and associated metrics. It examines which data quality actions and metrics may be implemented in various circumstances and proposes a maturity model to guide the growth of automation to assist data-driven regulatory decision making.

Source: Data Quality Framework for EU medicines regulation 

News from EDQM – Pharmeuropa 34.4 just released

Date of news: October 11, 2022

Pharmeuropa publishes all updated European Pharmacopoeia (Ph. Eur.) texts as well as texts that have undergone technical adjustments for public review. The Pharmeuropa 34.4 consultation period will end on December 31, 2022.

Source: Pharmeuropa 34.4 just released – European Directorate for the Quality of Medicines & HealthCare 

European Medicines Agency published guideline on practical guidance on the application form for centralised type IA and IB variations

Date of news: October 11, 2022

The guideline document should be read in conjunction with the EMA/CMDh Explanatory Notes on Variation Application Form (CMDh/EMA/133/2010) to help with the preparation of the application form for type IA and IB variations to be submitted in the Centralised Procedure.

Source: European Medicines Agency practical guidance on the application form for centralised type IA and IB variations 

News from ICH – The ICH process has moved to Step 2 with the proposed Q5A(R2) guideline

Date of news: October 11, 2022

The R2 revision preserves core ideas from the original Guideline while also making new suggestions on recognised and complementary techniques to preventing virus contamination of biotechnology products.

The Q5A(R2) EWG created a Step 2 Informational Presentation to summarise the substance of the proposed Guideline.

Source: https://database.ich.org/sites/default/files/ICH%20Q5A%28R2%29_Step2_Presentation_2022_1005.pdf 

EDQM has added Comparision of Chromatographic separation techniques: given in Ph. Eur. 10th and 11th Editions in its  Knowledge database

Date of news: October 13, 2022

Source: https://extranet.edqm.eu/4DLink1/pdfs/addon/20246.pdf 

News from MHRA – To enhance the safety of medicines and medical devices, the MHRA is evaluating its approach to engaging with healthcare professionals

Date of news: October 13, 2022

According to the MHRA, you can engage in this consultation anonymously, but if you enter your email address, we will add you to our mailing list to provide you with future opportunity to learn about or participate in our work.

Source: Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety – GOV.UK 

News from MHRA – Healthcare workers and their professional organisations have a unique opportunity to offer their perspectives and impact the MHRA’s safety communication and reporting systems.

Date of news: October 13, 2022

Source: Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems – GOV.UK 

U.S. FDA published final guidance on “Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA”

Date of news: October 13, 2022

The purpose of this final guidance is to assist original applicants and holders of approved NDAs, ANDAs, and BLAs in implementing chemistry, manufacturing, and controls (CMC) postapproval change using a comparability protocol (CP). 

A CP is a comprehensive, prospectively written plan for evaluating the impact of proposed postapproval CMC changes on the identity, strength, quality, purity, and potency of a drug product, including a biological product (i.e., product). These factors may relate to the product’s safety or effectiveness (i.e., product quality).

Source: Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA 

U.S. FDA published final guidance on “ANDA Submissions – Prior Approval Supplements Under GDUFA”

Date of news: October 14, 2022

This guidance is intended to help applicants who are prepared to submit to FDA prior approval supplements (PASs) and changes to PASs for ANDAs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). 

The guidance describes how the GDUFA affects PAS submissions. The guidance updates previous recommendations given in October 2017. 

This revision is being issued to incorporate the performance goals that FDA has agreed to meet in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years [Fiscal Years [FYs]] 2023-2027 (GDUFA III commitment letter). It also clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the performance goals in the GDUFA III commitment letter.

Source: Guidance for Industry-ANDA Submissions Prior Approval Supplements Under GDUFA 

News from TGA – After the European Medicines Agency has extended the validity of GMP certificates until the end of 2023, TGA  guided on the pathway and have created additional options for Australian Sponsors to maintain their GMP Clearance validity.

Month of news: October 2022

The TGA has developed three possibilities for Australian sponsors to preserve the validity of their GMP approval.

  1. The most recent proof is less than three years old.
  2. The most recent evidence is more than three years old, and you have not filed a renewal application that has been evaluated using our risk-based methodology.
  3. The risk-based methodology was used to evaluate your current apps.

Source: GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic | Therapeutic Goods Administration (TGA)

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