Pharma GMP News of the Week: 9-October-2022

Period: October 2, 2022 to October 8, 2022

The Central Drugs Standard Control Organization (CDSCO) of India has extended the deadline for obtaining the necessary permits for select medical device importers and manufacturers.

Date of news: October 1, 2022

The new medical device licencing framework for Class A and B goods was put into effect by CDSCO on October 1. However, the agency received requests to postpone the deadline from stakeholders and industry associations prior to the implementation date in order to prevent a disruption in the supply of goods. Manufacturers and exporters of Class A and B devices would have needed product permits if the law had been applied.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA1Nw== 

FDA published final guideline “FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals”

Date of news: October 3, 2022

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) was amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), allowing FDA to charge user fees for the review of specific premarket submissions received on or after October 1, 2022, such as premarket notification submissions (510(k)s). In order to accomplish certain performance objectives and make changes for the medical device review process, the FDA will be allowed to use the additional revenues received through user fees, in conjunction with the industry.

Source: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals 

FDA published draft guideline “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA”

Date of news: October 3, 2022

Owners of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be cited in an abbreviated new drug application (ANDA) or a prior approval supplement to an ANDA are the target audience for this guidance. The “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027” document outlines how FDA would implement a programme improvement that was agreed upon by the Agency and industry as part of discussions to reauthorize the Generic Drug User Fee Amendments (GDUFA) (GDUFA III commitment letter).

This advice explains the circumstances under which a DMF holder might ask for an early assessment, or “DMF prior assessment,” and the conditions under which the FDA would start an early examination of Type II API DMFs 6 months before an ANDA or PAS filing mentioning the DMF. Additionally, it offers suggestions for these DMF holders when submitting a request.

Source: Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA 

FDA published draft guideline “Facility Readiness: Goal Date Decisions Under GDUFA”

Date of news: October 3, 2022

In accordance with section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), this guideline explains how FDA intends to set a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h, submitted as a part of an original abbreviated new drug application (ANDA). The “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027” document outlines how FDA would implement a program improvement that was agreed upon by the Agency and industry as part of discussions to reauthorize the Generic Drug User Fee Amendments (GDUFA) (GDUFA III commitment letter).

Source: Facility Readiness: Goal Date Decisions Under GDUFA

FDA published final guideline “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules”

Date of news: October 3, 2022

In comparison to other dosage forms, tablets and capsules are often produced, prescribed, and may offer a variety of benefits such as the convenience of storage, portability, ease of administration, and accuracy in dosing. This guideline explains the requirement for Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.

Source: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules 

News from ICH “ICH E19 Guideline reaches Step 4 of the ICH Process”

Date of news: October 4, 2022

On September 27, 2022, the ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials reaches Step 4 of the ICH Process.

This Guideline is designed to give globally harmonised recommendations on the use of selective safety data collecting – by modifying the manner of safety data collection, it may be able to carry out clinical trials with improved efficiency by simplifying the data gathering process. This might make large-scale effectiveness and safety clinical studies with huge numbers of participants and long-term follow-up easier to undertake.

More information is available on the ICH E19 website.

Source: https://www.ich.org/news/ich-e19-guideline-reaches-step-4-ich-process 

News from EDQM “Implementation of the European Pharmacopoeia Supplement 11.1 – Notification for CEP holders”

Date of news: October 4, 2022

The European Pharmacopoeia (Ph. Eur.) Supplement 11.1 is now available. Holders of Certificates of Suitability to the Ph. Eur. Monographs (CEPs) are requested to amend their applications in accordance with the new monographs, which will be implemented on April 1, 2023.

Source: Implementation of the European Pharmacopoeia Supplement 11.1 – Notification for CEP holders – European Directorate for the Quality of Medicines & HealthCare 

FDA published final guideline “Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments”

Date of news: October 5, 2022

In accordance with the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027, this guidance describes how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the evaluation of an initial abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (GDUFA III commitment letter). A supplement or a modification to a supplement are not covered by this advice.

Source: Guidance for Industry | Information Requests and Discipline Review Letters under GDUFA 

FDA published final guideline “Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry”

Date of news: October 5, 2022

The Federal Food, Drug, and Cosmetic Act’s section 505(j) (21 U.S.C. 355(j)) allows for the submission of abbreviated new drug applications (ANDAs), and this guidance offers recommendations to the industry on post-complete response letter (CRL) teleconferences (post-CRL clarification teleconferences) between the FDA and ANDA applicants for the purpose of clarifying deficiencies identified in a CRL to an ANDA. This guidance’s processes are meant to assist ensure that post-CRL clarification teleconferences are well-managed and that they are planned and held within the time constraints specified in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027. (GDUFA III commitment letter).

The guideline in this document updates the guidance from December 2018 titled Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA. This amendment outlines how FDA will conduct post-CRL clarification teleconferences pursuant to the GDUFA performance objectives and incorporates the performance goals stated in the GDUFA III commitment letter that FDA has pledged to satisfy.

Source: Guidance for Industry | Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA 

FDA published final guideline “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry”

Date of news: October 5, 2022

This guideline defines an expanded pathway for talks between FDA and a prospective applicant who is planning to submit an abbreviated new drug application (ANDA) to FDA or an applicant who has already filed an ANDA for a complicated product under this guidance. This advice offers details on requesting and holding meetings with FDA for product development, pre-submission, mid-cycle review, enhanced mid-cycle review, and post-complete response letter scientific meetings.

This guideline updates the same-titled guidance that was released in November 2020. This revision is being made to reflect information on the types of complex product meetings and performance objectives specified in the Generic Drug User Fee Amendments Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027 (GDUFA III commitment letter), as well as details on how to request these meetings and the FDA’s methods for handling them.

Source: Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA 

FDA published final guideline “Competitive Generic Therapies”

Date of news: October 5, 2022

The FDA Reauthorization Act of 2017, or FDARA, established a procedure whereby the FDA may designate a medicine with “inadequate generic competition” as a competitive generic treatment upon the applicant’s request (CGT). A CGT medication’s abbreviated new drug application (ANDA) development and review may also be sped up by FDA at the applicant’s request.

The FDA Reauthorization Act of 2017, or FDARA, established a process by which the FDA may, at the request of the applicant, designate a medicine with “inadequate generic competition” as a competitive generic treatment (CGT). The FDA may also accelerate the creation and processing of an abbreviated new drug application (ANDA) for a CGT medication at the applicant’s request.

Source: Guidance for Industry: Competitive Generic Therapies 

News from EDQM “Revised general chapter on chemometrics published in Supplement 11.1 of the European Pharmacopoeia”

Date of news: October 5, 2022

Chemometric techniques applied to analytical data (5.21), the updated general chapter, has just been published in Supplement 11.1 of the European Pharmacopoeia (Ph. Eur.). The Ph. Eur. Commission accepted the draught during its 172nd Session in March 2022.

Numerous portions of the chapter have been fully rewritten or revised in light of recent events, and new sections/sub-sections have been added. This general revision contains the following:

(1) a revision to Section 1. A review of the sub-sections on Pre-processing (1-2-2-6) and Assessment and validation of chemometric techniques (1-3);

(2) two new sections on Independent component analysis (2-2) and Decision trees and random forests (2-6);

(3) an overview of the sections on Similarity measures (2-3), Clustering (2-5), Multiple linear regression (2-8), Principal component regression (2-9), Support vector machines for supervised classification (2-11), and Artificial neural networks (2-12);

(4) a new section, 3. Related application domains, with subsections on Chemometrics in chemical imaging (3-1) and Data fusion (3-2);

(5) an update of the Abbreviations and Glossary.

Source: Revised general chapter on chemometrics published in Supplement 11.1 of the European Pharmacopoeia – European Directorate for the Quality of Medicines & HealthCare 

MHRA updates its guidance “Medical devices: guidance for manufacturers on vigilance”

Date of news: October 6, 2022

MHRA updated its guidance with respect to the information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.

Source: Medical devices: guidance for manufacturers on vigilance – GOV.UK

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