Pharma GMP News of the Week: 12-December-2021

Period: December 05, 2021 to December 11, 2021

FDA publishes draft guideline on “IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations Guidance for Sponsor-Investigators”

Date of publication: December 07, 2021

The objective of this draft guidance is to recommend CMC information require for investigational new drug application (IND) submitted by a sponsor who is developing an individualized antisense oligonucleotide (ASO) drug product for a severely debilitating or life-threatening (SDLT) disease caused by a unique genetic variant where only a small number of individuals are prospectively identified (typically one or two).

Source: https://www.fda.gov

Download: https://www.fda.gov/media/154664/download

FDA publishes “draft guideline on IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations Guidance for Sponsor-Investigators”

Date of publication: December 07, 2021

The objective of this guidance provides recommendations for managing the administration of the individualized ASO drug product and conducting clinical assessments of the safety and treatment response during administration of the ASO drug product. The recommendations in this guidance are informed by experience with certain classes of well-characterized ASO drug products and by the ability to anticipate and manage some of the potential adverse events based on this prior experience with the ASO drug classes.

Source: https://www.fda.gov

Download: https://www.fda.gov/media/154663/download

FDA publishes “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products”

Date of publication: December 08, 2021

The purpose of this guidance is to discusses the applicability of FDA’s IND application regulations under part 312 (21 CFR part 312) to various clinical study designs that utilize Real-World Data. The guidance also clarifies the Agency’s expectations related to clinical studies using Real-World Data submitted to Food and Drug Administration in support of a regulatory decision regarding the effectiveness and safety of a drug.

Source: https://www.fda.gov

Download: https://www.fda.gov/media/154714/download

FDA publishes final guidance on “CMC Post approval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports”

Date of publication: December 09, 2021

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12. Specifically, the guidance describes CMC post approval manufacturing changes that FDA generally considers to have a minimal potential to have an adverse effect on product quality must be documented by applicants in an annual report.

Source: https://www.fda.gov

Download: https://www.fda.gov/media/106935/download

FDA publishes guidance on its website “Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry”

Date of publication: December 10, 2021

This published guidance gives information for permitted daily exposures (PDEs) for 3 additional residual solvents (RS): (1) 2-methyltetrahydrofuran, (2) cyclopentyl methyl ether, and (3) tert-butyl alcohol. The purpose of this document is to recommend permitted residue for above RS in pharmaceutical for the safety of the patient. The Q3C PDE levels are added and revised as new toxicological data for solvents become available.

Source: https://www.fda.gov

Download: https://www.fda.gov/media/138334/download

FDA publishes draft guidance on “Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry”

Date of publication: December 10, 2021

This draft document by FDA is published by FDA to assist prospective applicants, applicants, and holders of ANDAs with possible attachments which can be provided along with when preparing cover letters that accompany controlled correspondence to the Office of Generic Drugs, as well as original ANDAs, amendments, and supplements to approved ANDAs. These attachments do not replace the recommendations for the content of cover letters provided in other FDA guidance.

Source: https://www.fda.gov

Download: https://www.fda.gov/media/154762/download

MHRA has published interesting article on its blog on “Global reflections on international inspection transformation: ICMRA remote inspections”

Date of publication: December 10, 2021

In this blog article valuable insight provided about how global regulators have managed to perform regulatory oversight, inspections and assessments during the pandemic to support patients need and business continuity in terms of every aspects.

The article is linked with recently published white paper by ICMRA. ICMRA concluded that the “digital technologies in the remote conduct of inspections, evaluations, and assessments a key business continuity tool for regulatory oversight of certain activities and sites during the COVID-19 pandemic, which has proved valuable in the protection of public health in this emergency situation”.

Source: https://mhrainspectorate.blog.gov.uk/2021/12/10/global-reflections-on-international-inspection-transformation-icmra-remote-inspections/

White paper by ICMRA: https://www.icmra.info/drupal/sites/default/files/2021-12/remote_inspections_reflection_paper.pdf

European Commission’s Medical Devices Coordination Group (MDCG) provided new guidance “MDCG 2021-28: Substantial modification of clinical investigation under Medical Device Regulation”

Date of publication: December 9, 2021

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745.

The questions and answers describes on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

Source:

https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-28_en.pdf

https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-27_en.pdf

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