Pharma GMP News of the Week: 3-October-2021

Period: September 26, 2021 to October 2, 2021

News from MHRA Inspectorate blog: Updated data integrity requirements for GLP Monitoring Programme members

Date of news: September 27, 2021

The MHRA published the GXP Data Integrity Guidance in March 2018 and has subsequently led the development of an Organisation for Economic Co-Operation and Development (OECD) advisory document on data integrity.

The MHRA GXP Data Integrity Guidance was always intended to sit alongside additional regulatory guidance and should also continue to be used to supplement and support UK GLP facilities as it provides additional guidance primarily associated with the importance of a supportive organisational culture in order to embed and foster a strong data integrity culture within organisations.

The new OECD Data Integrity Advisory Document can be found here:

Download: https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/cbc/mono(2021)26&doclanguage=en

Source: https://mhrainspectorate.blog.gov.uk/

FDA has published draft guideline on: Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products

Date of publication: September 28, 2021

FDA states that the 21st Century Cures Act (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 Cures Act added section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355g). Pursuant to this section, FDA created a framework for a program to evaluate the potential use of real-world evidence (RWE) to help support the approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help to support or satisfy postapproval study requirements (RWE Program).

Download: https://www.fda.gov/media/152503/download

Source:https://www.fda.gov

FDA has published draft guideline on “Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices”

Date of publication: September 29, 2021

As per FDA, this guidance is intended to help clinical investigators comply with the following safety reporting requirements:

Investigational new drug application (IND) studies under § 312.64(b) (21 CFR 312.64(b)

Investigational device exemption (IDE) studies under § 812.150 (21 CFR 812.150)

Recommendations are provided to help investigators identify the following:

1. For drugs — Identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to institutional review boards (IRBs) under § 312.66 (21 CFR 312.66)

2. For devices — Identify safety information that meets the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and IRBs under § 812.150(a)(1) (21 CFR 812.150(a)(1))

Download: https://www.fda.gov/media/152530/download

Source: https://www.fda.gov

FDA has published draft guideline on “Microbiological Quality Considerations in Non-Sterile Drug Manufacturing”

Date of publication: September 29, 2021

As per FDA, this guidance is intended to assist manufacturers in assuring the control of microbiological quality of their non-sterile drugs (NSDs). The recommendations herein apply to solid non-sterile dosage forms, as well as semi-solid, and liquid non-sterile dosage forms (e.g., topically applied creams, lotions and swabs, and oral solutions and suspensions). NSDs can be prescription or nonprescription drugs, including those marketed under approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs), and nonprescription drugs without approved new drug applications which are governed by the provisions of section 505G of the FD&C Act (often referred to as over-the-counter (OTC) monograph drugs). These recommendations, if followed, will also assist manufacturers in complying with the current good manufacturing practice (CGMP) requirements for finished pharmaceuticals and active pharmaceutical ingredients (APIs).

Download: https://www.fda.gov/media/152530/download

Source: https://www.fda.gov

FDA has published draft guideline on “Benefit-Risk Assessment for New Drug and Biological Products”

Date of publication: September 29, 2021

According to FDA, the intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration (FDA or Agency) makes about new drug applications (NDAs) submitted under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as biologics license applications (BLAs) submitted under section 351(a) of the Public Health Service Act (PHS Act). This guidance first articulates important considerations that factor into the Center for Drug Evaluation and Research’s (CDER) and the Center for Biologics Evaluation and Research’s (CBER) benefit-risk assessments, including how patient experience data can be used to inform the benefit-risk assessment. It then discusses how sponsors can inform FDA’s benefit-risk assessment through the design and conduct of a development program, as well as how they may…

Download: https://www.fda.gov/media/152544/download

Source: https://www.fda.gov

FDA published final version of Q3B(R) Impurities in New Drug Products (Revision 3) on FDA site

Date of publication: September 29, 2021

This guidance provides recommendations for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesized new drug substances not previously registered in a region or member state. This guidance revises the ICH guidance of the same title that was issued in May 1997 and first revised in February 2003. The first revision clarified the 1997 guidance and included other changes. The revision also provided consistency with more recently published ICH guidances (e.g., Q3A(R) Impurities in New Drug Substances, Q3C Impurities: Residual Solvents, and Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances). This second revision provides clarification to Attachment 2.5

This guidance complements the ICH Q3A(R) guidance, which should be consulted for basic principles along with ICH Q3C when appropriate.

Download: https://www.fda.gov/media/71733/download

Source: https://www.fda.gov

EMA implements new measures to minimise animal testing during medicines development

EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles — replace, reduce and refine; commonly referred to as 3Rs — through EMA’s Innovation Task Force (ITF). This action will facilitate the development and implementation of New Approach Methodologies (NAMs) that are in line with the European Union legislation on the protection of animals used for scientific purposes.

ITF is a dedicated forum for early dialogue between regulators and developers of medicines to discuss innovative aspects such as emerging therapies, methods and technologies. Set up to ensure coordination across the Agency, the ITF is a multidisciplinary group that includes scientific, regulatory and legal competences. It will provide an opportunity to discuss 3R-compliant methods and facilitate their integration into the development and evaluation of medicinal products.

Source: https://www.ema.europa.eu/

EU agencies have updated their notice to specify that GMP and GDP certificates, and other time-limited authorizations are extended up to the end of 2022.

Date of publication: September 30, 2021

European regulators announced that good manufacturing practice (GMP) and good distribution practice (GDP) certificates and other authorizations shall be extended upto 2022.

This document provides guidance to marketing authorisation holders of medicinal products for human use (“MAH”) on regulatory expectations and flexibility during the COVID-19 pandemic. The document will be updated to address new questions and to adjust the content thereof to the evolution of the pandemic. For queries related to specific products that are not specifically addressed in this document, MAHs are invited to address the European Medicines Agency (for centrally authorised products) or the relevant national competent authorities (for nationally authorised products).

This document remains valid until further notice. It has been developed in cooperation between the European Commission, the Coordination group for Mutual recognition and Decentralised procedures – human (“CMDh”), the Inspectors Working Group and the European Medicines Agency (“EMA”).

The ultimate responsibility for the interpretation of EU legislation is vested on the European Court of Justice and therefore the content of this document is without prejudice to a different interpretation that may be issued by the European Court of Justice.

See the notice: https://ec.europa.eu/health/sites/default/files/human-use/docs/guidance_regulatory_covid19_en.pdf

FDA issued draft guidance on Electronic Submission Template for Medical Device 510(k) Submissions for comment purposes

Document issued on September 29, 2021.

FDA is issuing this draft guidance document to introduce submitters of premarket notification

(510(k)) submissions to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support 510(k) electronic submissions to FDA. This draft guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.

Download: https://www.fda.gov/media/152429/download

Source: https://www.fda.gov

WHO is requesting input on draft guideline on WHO Biowaiver Project- Preparation for cycle V 5 (2022):

Prioritization exercise of active pharmaceutical ingredients on the WHO Model List of Essential Medicines for solubility determination and Biopharmaceutics Classification System-based classification.

Download:  https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/current-projects/qas21_902_prioritization_exercise_of_apis_for_cycle_v.pdf?sfvrsn=b7fe265f_5

EDQM news: Certification of suitability: revised terms of reference and rules of procedure

Date of news: September 27, 2021

A revised version of the terms of reference and rules of procedure for the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure has been adopted by the Certification Steering Committee and is available on the website of the European Directorate for the Quality of Medicines & HealthCare (EDQM): Terms of Reference and Rules of Procedure (PA/PH/CEP (01) 1, 12 R).

This revision was undertaken to clarify the title and certain working procedures, and to take into account organisational changes in the EDQM Certification of Substances Department.

Reference:  https://www.edqm.eu/sites/default/files/medias/fichiers/TermsOfReference/cep_terms_of_reference_for_certification_of_suitability_paphcep_01_1_12r.pdf

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