Pharma GMP News of the Week: 23-January-2022

Period: January 09, 2022 to January 22, 2022

MHRA’s new proposals for the future clinical trial legislation

Published on: January 17, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has invited to contribute their views on far-reaching proposed revisions to the clinical trial legislation in the UK. As per MHRA, rhe objective of this proposal is to “improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines”.

Consultation period is eight-week.

Source:

https://www.gov.uk/government/news/new-proposals-for-the-future-of-uk-clinical-trial-legislation

https://www.gov.uk/government/consultations/consultation-on-proposals-for-legislative-changes-for-clinical-trials

FDA announced regarding extending On-Site Surveillance Inspections for another 2 Weeks Because Of Omicron

Date of news: January 21, 2022

FDA has announced that the US Food and Drug Administration is not going to conduct on-site surveillance inspections for another two weeks at a minimum.

The agency said on January 21, 2022 that “The FDA is extending the pause on domestic surveillance inspections through Feb. 4 with the goal of restarting these activities as soon as safely possible”.

As per FDA, “The agency continues to conduct both foreign and domestic mission-critical inspections … leveraging a variety of tools, including remote assessments and import operations surveillance”.

Source: https://medtech.pharmaintelligence.informa.com/MT144974/FDA-Extends-On-Site-Surveillance-Inspections-Freeze-Another-2-Weeks-Because-Of-Omicron

EU introduces clinical trials transformation initiative

Month of news: January 2022

Source:

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/accelerating-clinical-trials-eu-act-eu-delivering-eu-clinical-trials-transformation-initiative_en.pdf

EU release a note for version 5.0 of the Harmonised Technical Guidance for eCTD Submissions in the EU

Date for coming into effect (version 5.0): February 1, 2022

Harmonised Technical Guidance for eCTD Submissions new version has been drafted by the HHG and reviewed by the eSubmission Expert Group and the CMDh before it’s acceptance.

Note: http://esubmission.ema.europa.eu/tiges/docs/Release%20note%20for%20EU%20Harmonised%20technical%20eCTD%20guidance%20version%205.0_for%20publication.pdf

Harmonized guidance: http://esubmission.ema.europa.eu/tiges/docs/eCTD%20Guidance%20v5.0_adopted%20version.pdf

Industry is asking more time for reporting manufacturing volume data that is required as per “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal FD & C Act; Draft Guidance for Industry (October 2021)”; under the “Coronavirus Aid, Relief, and Economic Security Act (CARES Act)”.

US FDA has recently publish the guidance “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal FD & C Act; Draft Guidance for Industry (October 2021)”; under the CARES Act. As per this guidance, each Drugmakers and active pharmaceutical ingredient (API) needs to provide the manufacturing volume they produced during the calendar year 2020 and calendar year 2021.  These reports for calendar year 2020 need to be submitted February 15, 2022 and reports for calendar year 2021 need to be submitted by May 16, 2022.

The Association for Accessible Medicines (AAM) requested to FDA for delay the reporting date for 2020 data in September 2022.

Furthermore, PhRMA requested that FDA for exemptions for certain types of biologics to cover made-to-stock cell and gene therapy products. FDA proposed to exempt two categories of products from the reporting requirement and those are “blood and blood components for transfusion” and “cell and gene therapy products”.

Example format for reporting:

Pack wise and Month wise volume distributed

ANDA No.Product NameStrengthPack typeNDCJan 2020Feb 2020Mar 2020Apr 2020May 2020Jun 2020Jul 2020Aug 2020Sep 2020Oct 2020Nov 2020Dec 2020

Draft guideline: https://www.fda.gov/media/153665/download

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