Pharma GMP News of the Week: 10-October-2021

Period: October 3, 2021 to October 9, 2021

News from FDA: S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals

Date of issue: October 6, 2021

This Addendum is to be used in close conjunction with ICH S1A Guideline on the Need for Carcinogenicity Studies for Pharmaceuticals, S1B Testing for Carcinogenicity of Pharmaceuticals, and S1C(R2) Dose Selection for Carcinogenicity Studies. The Addendum is complementary to the S1 Guidelines.

Download draft guideline: https://www.fda.gov/media/152777/download

Source: https://www.fda.gov

ICH published ICH M7(R2) draft Guideline and Addendum reaches Step 2 of the ICH process

Date of issue: October 6, 2021

The ICH M7(R2) draft Guideline and Addendum on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 2 of the ICH process on 6 October 2021 and now enters the public consultation period.

The ICH M7 (R2) Addendum provides useful information regarding the acceptable limits of known mutagenic impurities/carcinogenic and supporting monographs.

7 new compounds have been added in this revision: Acetaldehyde, Dibromoethane, Epichlorohydrin, Ethyl Bromide, Formaldehyde, Styrene, and Vinyl Acetate.

Additionally, a Step 2 Informational Presentation has also been developed by the Maintenance Expert Working Group.

Download: https://database.ich.org/sites/default/files/ICH_M7R2_Guideline-Addendum_Step2_ForPublicConsultation_2021_1006_1.pdf

Source: https://www.ich.org/

News from ICH: The ICH E8(R1) Guideline reaches Step 4 of the ICH Process

Date of news: October 6, 2021

The ICH E8(R1) Guideline on General considerations for Clinical Studies reached Step 4 of the ICH Process on 6 October 2021.

Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. ICH E8(R1) provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.

This modernisation of ICH E8 is the first step towards the Renovation of Good Clinical Practice initiated in 2017. The revision incorporates the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials. 

Download: https://database.ich.org/sites/default/files/E8-R1_Guideline_Step4_2021_1006.pdf

Source: https://www.ich.org/

Drug Administration (FDA) has revised its guidance with more flexibility – Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Date of issue: October 6, 2021

This revised draft guidance describes how FDA intends to apply certain provisions of section 503A of the FD&C Act to human drug products that are compounded by state-licensed pharmacies that are not outsourcing facilities for distribution within a hospital or health system. First, the revised draft guidance addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient (section 503A(a) of the FD&C Act). Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product (section 503A(b)(1)(D) of the FD&C Act). This guidance does not apply to human drug products compounded by outsourcing facilities under section 503B of the FD&C Act, compounded drug products that are not distributed for use within a hospital or health system, or drug products compounded for use in animals.

Download: https://www.fda.gov/media/97353/download

Source: https://www.fda.gov

The European Commission’s Medical Devices Coordinating Group (MDCG) on October 04, 2021 issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are placed on the EU market.

Date of issue: October 04, 2021

The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This approach uses a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness, local vs. systemic effect, potential toxicity, the part of the body affected by the use of the device and if the device depends on a source of energy. The criteria can then be applied to a vast range of different medical devices and technologies. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR). They correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:20121.

Download: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf

Source: https://ec.europa.eu/

The European Commission (EC) published new document “Good Lay Summary Practice” (“GLSP”), with recommendations on how to prepare, write, translate, and disseminate summaries of clinical trial results in lay language.

Date of publication: October 04, 2021

This is a mandatory requirement laid out in Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“EU CTR”) and a transparency obligation to all trial participants and the interested public.

Download: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/glsp_en.pdf

Source: https://ec.europa.eu/

The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Date of publication: October 05, 2021

This final rule establishes procedures and criteria related to requests for De Novo classification (“De Novo request”) and provides a pathway to obtain marketing authorization as a class I or class II device and for certain combination products. These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation.

Source: https://www.federalregister.gov/documents/2021/10/05/2021-21677/medical-device-de-novo-classification-process

Draft monograph on Oxygen (98 per cent) published for comment in Pharmeuropa

Date of news: October 06, 2021

A new draft monograph, Oxygen (98 per cent) (3098), has been published for comment in this quarter’s issue of Pharmeuropa (33.4), the European Pharmacopoeia (Ph. Eur.) online forum. The deadline for comments on the new monograph is 31 December 2021.

This draft monograph is the outcome of a thorough examination of the substantial response to the request for feedback issued in April 2020 and which prompted lively and constructive discussions with regulatory experts in the field, as well as a series of dedicated Ph. Eur. expert meetings.

Source: https://www.edqm.eu/

Pharmeuropa 33.4 released

Date of news: October 5, 2021

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.4 is 31 December 2021.

Source: https://www.edqm.eu/

European Pharmacopoeia Supplement 10.7 available

Date of news: October 04, 2021

The European Pharmacopoeia (Ph. Eur.) Supplement 10.7 is now available and will be applicable in 39 European countries as of 1 April 2022.

This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions are already available to purchase via the EDQM Store.

Source: https://www.edqm.eu/

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