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

Period: October 16, 2022 to October 22, 2022

MHRA has revamped Software and AI as a Medical Device Change Programme

Date of news: October 17, 2022

Software (and AI in particular) has a wide range of uses in both health and social care, and it is becoming more and more prevalent in health systems. Many of these applications will fall within the purview of medical devices regulation. In order to ensure that patients, the general public, and healthcare professionals have access to the most advanced medical technology, it is becoming more and more crucial that medical device regulation be effective.

This work plan will bring about radical change to create a regulatory framework that offers a high level of patient and public protection while also ensuring that the UK is the hub of responsible innovation for medical device software.

Source: Software and AI as a Medical Device Change Programme – GOV.UK 

In revised CPGs, the FDA addresses alternate inspection instruments and requirements for nitrosamine evaluations

Date of news: October 17, 2022

The FDA has revised two compliance programme guidelines (CPGs) that cover pre-approval inspections (PAIs) and routine good manufacturing practise (GMP) monitoring inspections.

The updates reflect the FDA’s use of alternative tools for evaluating facilities in lieu of onsite inspections, which were heavily used during the pandemic, as well as newly added sections covering nitrosamine risk assessments and the incorporation of International Council for Harmonization (ICH) guidelines. Both CPGs took effect on October 17.

Source: 

Compliance program 7346.832 Preapproval Inspections

Compliance program 7356.002 Drug Manufacturing Inspections 

EMA has published Staff Working Document on Vulnerabilities of the global supply chains of medicines: Structured Dialogue on the security of medicines supply

Date of news: October 17, 2022

This Staff Working Document summarises the main findings of the stakeholders’ work on pharmaceutical supply chain challenges in general, as well as presenting the draught methodology for identifying Critical Medicines and, once identified, approaches that could be used to identify vulnerabilities in the supply chain of those medicines to improve supply security.

The study also considers the issues that may be connected with specific vulnerabilities, such as dependence in a highly globalised pharmaceutical business, the regulatory environment, and the green and digital transitions. The Structured Dialogue has increased communication and information exchange among stakeholders in the supply chain.

Source: Staff Working Document on Vulnerabilities of the global supply chains of medicines – Structured Dialogue on the security of medicines supply 

Regarding chemical applications for polymorphs, EDQM modifies CEP policy

Date of news: October 18, 2022

The EDQM has changed its stance on polymorph chemical uses. A request for a Certificate of Suitability to European Pharmacopoeia monographs (CEP) for a specific polymorphic form (as a grade) is now available even if the sentence “the substance demonstrates polymorphism” is not specified in the EP’s relevant individual monograph’s “Characters” section.

In such circumstances, the applicant should include data from the literature or any other suitable proof to indicate that the material exhibits polymorphism. The substance specification should contain an analytical technique adequate for characterising the proposed polymorphic form. If the request is granted, the CEP will be updated with a subtitle for the specific polymorph, as well as the technique used to characterise it.

Source: EDQM changes CEP policy regarding chemical applications for polymorphs – European Directorate for the Quality of Medicines & HealthCare 

FDA Published draft guideline on “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care”

Date  of news: October 21, 2022

This draft guideline was created by the FDA to recommend specific revisions to the FDA guidance paper “Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff.” 

This guidance proposes specific updates to the guidance that clarify how the programme may apply to certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or health care disparities. The current Breakthrough Devices Program guidelines will continue in force until this draught guidance is approved.

Source: Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care 

FDA Published final guideline on “Human Gene Therapy for Neurodegenerative Diseases”

Date of news: October 21, 2022

This advice gives recommendations to sponsors developing human gene therapy (GT) products for adult and paediatric patients suffering from neurodegenerative disorders. Neurodegenerative diseases are a diverse set of conditions defined by gradual deterioration of the central nervous system or peripheral nervous system structure and function. The genesis, frequency, diagnosis, and therapy of these diseases vary, and they include both hereditary and age-related disorders. This document focuses on product development, preclinical testing, and clinical trial design. This guideline finalises the January 2021 draft guidance of the same title.

Source: Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry 

FDA Published draft guideline on “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs”

Date of news: October 21, 2022

This guideline is designed to help applicants who are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, 18 including integumentary and mucosal (e.g., vaginal) membranes, referred to as 19 topical products. Topical 21 goods (other than topical solutions) are categorised as complex products due to the complicated mode of administration associated with these products, 20 which are often locally active, and the possible complexity of some formulations.

Source: Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs 

FDA Published draft guideline on “In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs”

Date of news: October 21, 2022

The purpose of this advice is to assist applicants who are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are referred to as topical products. Topical treatments (other than topical solutions) are categorised as complex products due to the complicated route of administration associated with these products, which are often locally active, and the possible complexity of some formulations. This document contains suggestions for in vitro release test (IVRT) studies that may be used to compare a proposed generic (test) topical product to its reference standard (RS) in order to support a demonstration of bioequivalence (BE) to the reference listed medicine (RLD). The RLD is typically used as the reference standard.

Source: Draft Guidance for Industry: In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs 

FDA Published draft guideline on “In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs”

Date of news: October 21, 2022

This guideline is designed to help applicants who are submitting abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes, which are referred to as “topical products” in this document. Topical treatments (other than topical solutions) are categorised as complex products due to the complicated route of administration associated with these products, which are often locally active, and the possible complexity of some formulations. This document contains recommendations for in vitro permeation test (IVPT) studies that compare a proposed generic (test) topical product to its reference standard (RS) in order to provide a demonstration of bioequivalence (BE) to the reference listed drug (RLD). The RLD is typically used as the reference standard.

Source: Draft Guidance: In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs 

FDA Published final guideline on “Multiple Endpoints in Clinical Trials Guidance for Industry”

Date of news: October 21, 2022

This guidance provides sponsors and review staff with the Agency’s thinking on the problems posed by multiple endpoints in the analysis and interpretation of study results, as well as how to manage these problems in clinical trials for human drugs, including drugs subject to licencing as biological products. Most clinical trials in drug development have numerous endpoints to assess the treatment’s effects and demonstrate the drug’s capacity to improve one or more disease features. As the number of endpoints studied in a single trial rises, the risk of reaching incorrect conclusions regarding a drug’s effects on one or more of those endpoints increases if sufficient multiplicity adjustment is not made.

The goal of this guideline is to present several techniques for grouping and ranking endpoints for analysis, as well as to use certain well-known statistical approaches for controlling multiplicity inside a research, in order to reduce the possibility of reaching incorrect conclusions regarding a drug’s effects. Based on an investigation where the danger of incorrect findings has not been adequately addressed, a result can lead to inaccurate or misleading claims about a drug’s effects.

Source: https://www.fda.gov/media/162416/download 

The proposed ICH M11 guideline has reached Step 2 of the ICH process

Date of news: October 21, 2022

A comprehensive clinical protocol organisation with standardised content is proposed by this new guideline, along with: a Template outlining the protocol’s format and structure, including its table of contents, common headers, and contents; and a Technical Specification outlining the conformance, cardinality, and other technical characteristics that permit the interoperable electronic exchange of protocol content.

Source: https://www.ich.org/page/multidisciplinary-guidelines 

To comment on proposed monographs published in Pharmeuropa 34.4, CEP holders are invited.

Date of news: October 21, 2022

The list of substances for which draught updated monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 34.4 is a useful resource for those who have Certificates of Suitability to the European Pharmacopoeia (CEPs) monographs. The compounds that are impacted by these changes and for which a CEP has been granted are listed in the table below.

Users are advised to sign up on the European Directorate for the Quality of Medicines & Healthcare (EDQM) website for free (Pharmeuropa, Pharmeuropa Bio & Scientific Notes) in order to have access to Pharmeuropa.

Source: https://www.edqm.eu/en/-/cep-holders-invited-to-comment-on-draft-monographs-published-in-pharmeuropa-34.4

The CDSCO of India allocates oncology medical devices to risk groups under MDR in 2017.

Month of news: October 2022

CDSCO has given risk categories to 48 oncology medical devices. CDSCO has classified two medical devices in its highest risk category, D. An alternating electric field antimitotic cancer treatment system and a coronary artery brachytherapy system applicator are the devices. 

The remaining devices are distributed throughout the other three categories, with class C accounting for more than half of the total. Cryosurgical sets and capsular tension rings are examples of class C equipment.

In addition, the regulatory body produced a list of risk categories for 95 oral medical equipment. The majority of dental devices are low risk, prompting CDSCO to classify them as A and B, however there are exceptions.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTExOQ==

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