Pharma GMP News of the Week: 4-December-2022
Period: November 27, 2022 to December 3, 2022
In order to engage with DARWIN EU®, the Data Analysis and Real-World Interrogation Network, EMA has chosen the first group of PDF icon data partners.
Date of news: November 23, 2022
Source: DARWIN EU® welcomes first data partners | European Medicines Agency
FDA has published guidance “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies”
Date of news: November 28, 2022
The FDA examined information from stakeholders, including doctors, scientists, and patients concerned about adequate access to FMT for patients with C. difficile infection who are not responding to traditional therapy, in developing this policy. The FDA created this strategy to enable patients gain access while also addressing and managing the dangers that centralised manufacture in stool banks poses to persons receiving such goods.
This guidance supersedes the guidance entitled “Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,” which was issued in March 2016.
FDA has published draft guidance “Draft Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)”
Date of news: November 29, 2022
The FDA is releasing Edition 5 (Final Guidance) to replace Edition 4 (Final Guidance), which was issued in 2006. With the exception of minor or editorial modifications, Edition 5 (Final Guidance) retains the questions and answers from Edition 4 (Final Guidance). Furthermore, the FDA is providing this advice, Edition 5 (Draft Guidance), to solicit feedback on the additional or updated questions and answers. It should be noted that some questions and answers from Edition 4 (Final Guidance) have been withdrawn and moved to this Edition 5 (Draft Guidance) for feedback if the FDA concluded that the question and answer needed to be altered in any way.
Source: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic
A senior FDA official advocates for cloud-based regulatory reviews
Date of news: November 30, 2022
At a symposium on drug master files (DMFs) and structured data submissions on November 30, a top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving toward this platform through ongoing internal and international harmonisation initiatives.
Date of news: Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions November 30, 2022
The European Commission updates data for potential reference labs.
Date of news: November 30, 2022
The informational package for potential EU reference laboratories has been revised by the European Commission. To give applicants important information regarding the function of the laboratories and the selection procedure, officials initially released the pack in July.
FDA has published draft guidance “Statistical Approaches to Establishing Bioequivalence”
Date of news: December 2, 2022
Part 320 specifies the requirements for submitting bioavailability (BA) and bioequivalence (BE) data in investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements, as well as the definitions of BA and BE and the types of in vitro and in vivo studies appropriate for measuring BA and establishing BE (21 CFR part 320). This advice includes recommendations for meeting Part 320 requirements for all drug products.
Source: https://www.fda.gov/media/163638/download
FDA has published draft guidance “ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions”
Date of news: December 2, 2022
The Food and Drug Administration (FDA) is issuing this revised draught guidance to incorporate programme enhancements related to the content, timing, and assessment of a pre-submission facility correspondence (PFC)2 within the abbreviated new drug application (ANDA) assessment program3 agreed upon by the Agency and industry as part of the Generic Drug User Fee Amendments (GDUFA III) reauthorization, as described in GDUFA Reauthorization Performance Goals and Program E. 4 This guideline updates the proposed guidance for industry on ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications issued in November 2017. (Pre-Submission Facility Correspondence).
Source: https://www.fda.gov/media/163643/download
EMA published “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November – 1 December 2022”
Date of news: December 2, 2022
India will revise its New Drugs and Clinical Trials Rules to include information on non-clinical test methods
Date of news: November 22, 2022
The Indian government has recommended revisions to the 2019 New Drugs and Clinical Trials Rules. Officials intend to revise the Act to provide more information regarding non-clinical testing procedures.
The Act now specifies that “requirements for non-clinical investigations have been stipulated in the Second Schedule.” The amended paper will include a new section on particular sorts of testing methodologies for determining the safety and efficacy of new medications.
As non-clinical testing approaches that new drug developers may use, the update cites cell-based assays, organ chips and micro physiological systems, advanced computer modelling, various human biology-based test methods, and animal research. The draught is now available for comment.
Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTI4Nw==