Pharma GMP News of the Week: 24-October-2021

Period: October 17, 2021 to October 23, 2021

FDA published draft guideline for comments “Data Standards for Drug and Biological Product Submissions Containing Real-World Data” Comments to be submitted by January 21, 2022

Date of draft published: October 21, 2021

The 21st Century Cures Act, signed into law on December 13, 2016, is intended to accelerate medical product development and bring innovations faster and more efficiently to the patients who need them. Among other provisions, the 21st Century Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Pursuant to this action, calling for FDA to issue guidance on the use of real-world evidence (RWE) in regulatory decision-making, FDA has created a framework for a program to evaluate the potential use of real-world data (RWD) to generate RWE to help support the approval of new indication(s) for drugs already approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or to help support or satisfy post-approval study requirements (RWE Program).

Download: https://www.fda.gov/media/153341/download

On ICH’s 30th Anniversary, ICH has published document with an overview of ICH’s history and current work.

Date of news: October 19, 2021

ICH has announceed the publication of a 30th Anniversary document. This follows ICH’s 2020 celebration of 30 years of harmonisation activity. It provides an overview of ICH’s history and current work, as well as views of different stakeholders on how ICH has contributed to better health and ICH’s future directions in the next 10 years.

You can find the publication can be found on following link.

Download: https://admin.ich.org/sites/default/files/inline-files/ICH30thAnniversaryPublication_Interactive_2021_1014.pdf

Source: https://ich.org

Pharmacopoeial Discussion Group (PDG) prepares pilot for global expansion of membership

Date of news: October 18, 2021

As per thenews by EDQM, the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with the World Health Organization (WHO) as an observer, is preparing a pilot to integrate additional world pharmacopoeias. This is a critical step in the PDG’s commitment to expanding recognition of harmonised pharmacopoeial standards with a view to achieving global convergence.

Since it was founded in 1989, the PDG has successfully harmonised and maintained 29 general chapters, including such important analytical procedures as Dissolution Testing, Sterility and Microbiological Examination. In addition, the PDG has harmonised 46 excipient monographs and has approximately 20 new texts in its pipeline. The aim of the three founding pharmacopoeias is to extend this significant success story to further jurisdictions/regions and to create an inclusive global platform from which to elaborate harmonised pharmacopoeial standards.

Download document for more information: https://www.edqm.eu/sites/default/files/medias/fichiers/PressRelease/press-release-pheur-pdg_prepares_pilot_for_global_expansion-october_2021.pdf

Source: https://www.edqm.eu/

Source: https://www.fda.gov/

The US House of Representatives passed a following bill on October 19, 2021, H.R. 4369, which promotes advanced manufacturing through the creation of national centers for excellence in continuous manufacturing.

H.R. 4369, the “National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act,” was introduced by Pallone and Health Subcommittee Ranking Member Brett Guthrie (R-KY). The bill would amend the 21st Century Cures Act to provide the Food and Drug Administration (FDA) with the authority to designate institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing for pharmaceuticals as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing. Such Centers would work with FDA to craft a national framework for advanced and continuous pharmaceutical manufacturing, including workforce development, standardization, and collaboration with manufacturers. The bill passed on the House Floor by a vote of 368-56. 

The bill would designate certain universities as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing, allowing them to work with FDA and industry to further develop and implement advanced and continuous manufacturing technology. The bill would also authorize $100 million in funding to support the effort. Pallone spoke in favor of the bill on the House floor.

Download: https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/CM%20Bill%20Text.pdf

Source: https://energycommerce.house.gov/newsroom/press-releases/pallone-and-eshoo-praise-house-passage-of-four-public-health-bills

European Commission has provided draft Clinical Trial Regulation (Version 4.1 (September 2021) – Clinical Trials Regulation (EU)No 536/2014 Draft Questions & Answers)

Date of release: October 14, 2021

The European Commission has published an updated question and answer guidance on the Clinical Trials Regulation (CTR), which is ready to go into effect this January.

Download: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf

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