Pharma GMP News of the Week: 1-May-2022

Period: April 24, 2022 to April 30, 2022

FDA Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research issued guidance on “Providing Submissions in Electronic Format — Postmarketing Safety Reports”

Date of issue: April 27, 2022

The objective of the guideline is to assist industry for regulatory submissions in electronic format to CDER and CBER. The document provides information regarding the electronic submission of postmarketing reports as per the following provisions of regulations:

21 CFR 314.98 and 314.80 – approved NDAs and ANDAs, including combination products or drug constituent parts with approved NDAs or ANDAs.

21 CFR 600.80 – approved BLAs, including combination products or biological product constituent parts with approved BLAs.

21 CFR 310.305 – prescription drug products marketed for human use those are not approved NDAs or ANDAs

21 CFR part 4, subpart B – additional reports for combination products with approved BLAs, ANDAs or NDAs

Source: https://www.fda.gov/media/71176/download 

FDA Center for Drug Evaluation and Research  issued guidance on “Electronic Submission of IND Safety Reports Technical Conformance Guide”

Date of issue: April 29, 2022

The objective of the guideline is to provide specifications, general considerations, and recommendations on how to submit electronic IND application safety reports to the CDER or CBER. This is the supplement guide to the draft guidance “Providing Regulatory Submissions in Electronic Format: IND Safety Reports dated October 2019”, as per requirements of section 745A(a) of the FD&C Act.

Source: https://www.fda.gov/media/132078/download 

FDA Center for Drug Evaluation and Research  issued guidance on “FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products”

Date of issue: April 29, 2022

The objective of the guideline is to assist in electronic submission of individual case safety reports (ICSRs) and attachments to the CDER and CBER in the FDA . This guideline describes technical approach from FDA for submitting ICSRs, for adding its regionally controlled terminology, and for adding FDA FAERS regional data elements that are not given in the ICH E2B (R3) Implementation Guideline (IG) for the following products:

  • NDAs and ANDAs for human use
  • Prescription drug products for human use with no an approved applications 
  • OTC for human use
  • BLAs for human use.

Source: https://www.fda.gov/media/98536/download 

FDA Center for Drug Evaluation and Research  issued guidance on “E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility”

Date of issue: April 29, 2022

Source: https://www.fda.gov/media/81913/download 

FDA Center for Drug Evaluation and Research  issued guidance on “E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility”

Date of issue: April 29, 2022

Source: https://www.fda.gov/media/81904/download 

MHRA published Guidance on “Innovative Licensing and Access Pathway” that supports innovative approaches to the timely, safe, and efficient medicine development to improve patient access.

Date of last update: April 29, 2022

The ILAP aims to speed up the time to market and  provide patient access to medicines. It covers biological medicines, new chemical entities, repurposed medicines, and new indications. 

The Innovative Licensing and Access Pathway is open to non-commercial and commercial developers of medicines within the UK or global. 

Note: ILAP – Innovative Licensing and Access Pathway

Source: https://www.gov.uk/guidance/innovative-licensing-and-access-pathway#full-publication-update-history 

MHRA published Guidance on “Compliance Monitor (CM) Overview and Application Process”

Date of publication: April 29, 2022

As per the MHRA website, they are going to run a pilot scheme to monitor organizations that fail to comply with GMP and GDP and are referred to the IAG post inspection and compliance escalation process being initiated for them. (Note:  IAG – Inspection Action Group)

The process will support the agency in focusing resources on completion of the routine risk-based inspection for ensuring patient safety.

During this process IAG will monitor and support the implementation of an agreed Compliance Protocol. As per the details provided on the website, “A company offered the CM oversight route may choose not to accept this and can continue with the routine IAG process”.

This process from the CM will help the company to focus on remediation of the CAPA and augment the oversight of the MHRA.

Source: https://www.gov.uk/government/publications/compliance-monitor-cm-overview-and-application-process 

PMDA, Japan published translation of “Amendment to Basic Principles on Global Clinical Trials”

Month of publication: April 2022

Source: https://www.pmda.go.jp/files/000246184.pdf 

US Food and Drug Administration (FDA) officials asserted at a 26 April Generic Drug Forum (GDF) that firms with weak quality cultures are more susceptible to submit abbreviated new drug applications (ANDA) with data integrity problems than companies with stronger culture. Yet officials continue to see data integrity problems across the board, affecting all elements of ANDA submissions.

Information on “Generic Drugs Forum 2022: The Current State of Generic Drugs” by FDA that conducted  on April 26 – 27, 2022

As per the FDA representatives, organizations with weak quality cultures are more susceptible to have data integrity concerns in the submitted ANDA applications compared to the companies with stronger culture. 

During this forum, FDA officials discussed the common deficiencies found in submitted ANDAs and lessons learned from remote interactive evaluations.

Watch entire Day 1 and Day 2 as using following videos:

Generic Drugs Forum 2022: The Current State of Generic Drugs – Day 1

Generic Drugs Forum 2022: The Current State of Generic Drugs – Day 2

European Commission’s Medical Device Coordination Group issued guideline to help define ‘borderline’ products

Month of issue: April 2022

The guideline is issued to clarify how developers identify the correct regulatory framework for these so-called “borderline”. This document provides a flowchart to determine whether the product is meeting the definition of a medical device under the MDR.

The purpose of the flow chart is to decide “whether a product fulfills the definition of a medical device per the MDR in order to ensure a consistent approach in the decisions concerning the borderline between medical devices and medicinal products.”
Source:https://ec.europa.eu/health/system/files/2022-04/mdcg_2022-5_en.pdf

ICH published “The ICH E8(R1) Introductory Training Presentation” on the ICH website

Date of publication: April 28, 2022

The ICH E8(R1) Guideline is related to General Considerations for Clinical Studies. The guideline is reached Step 4 of the ICH Process on 6 October 2021.

This Step 4 Presentation (Introductory Training) is developed by the Experts.

Source: https://database.ich.org/sites/default/files/ICHE8%28R1%29_Step4Presentation_2022_0408.pdf

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