Pharma GMP News of the Week: 11-December-2022
Period: December 4, 2022 to December 10, 2022
The European Commission presents a strategy to create emergency diagnostic regulatory channels.
Date of publication: November 30, 2022
The European Commission intends to investigate and establish diagnostic regulatory channels “to provide both an adequate degree of oversight and rapid market entry in the case of an emergency.”
The Commission’s Health Emergency Preparedness and Response Authority (HERA) highlights diagnostics as critical medical countermeasures in its State of Health Preparedness Report, citing their importance in epidemiological monitoring as well as the identification of the most appropriate therapy. Diagnostics, as HERA points out, allow pathogen identification and antibiotic susceptibility testing.
Source: State of Health Preparedness Report
The EU sets implementing regulations for devices that do not have a medical function
Date of news: December 1, 2022
Under the Medical Devices Regulation, the European Union has produced implementing regulations that provide uniform requirements and rules for the reclassification of items that do not have a medical purpose (MDR).
MDR includes an appendix that specifies classes of items such as contact lenses, dermal fillers, and liposuction machines that do not have a medical function but are nevertheless regulated. The regulation is written to apply to products “taking into account the state of the art, and in particular existing harmonized standards for analogous devices with a medical purpose, based on similar technology, and states that common specifications must address risk management and, if necessary, clinical safety evaluation.
FDA published final guideline “E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials”
Date of news: December 05, 2022
The purpose of this guideline is to offer internationally unified guidance on the use of selective safety data gathering in specified pre-approval or post-approval late-stage clinical studies. Selective safety data collection refers to the collecting of limited amounts of particular types of data in a clinical study following careful analysis of the criteria that would warrant such an approach. It may be able to conduct clinical trials more efficiently by adapting the procedure and simplifying the approach to safety data gathering.
Source: https://www.fda.gov/media/163670/download
FDA published final guideline “Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer”
Date of news: December 06, 2022
This document provides recommendations for sponsors of investigational new drug (IND) and biologics licence application (BLA) submissions under 42 U.S.C. 262 and 21 CFR Parts 312 and 601 on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies. Because this guidance is based on accumulated scientific and regulatory experience for PD-1 and PD-L1 drugs, it does not address the development of alternative dosing regimens for other drugs or biologics, changes in route of administration, or novel formulations of previously approved PD-1/PD-L1 products.
FDA published draft guideline “Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations”
Date of news: December 06, 2022
Aluminum toxicity in parenteral nutrition (PN) is a serious safety problem, demanding that PN products fulfil the standards for aluminium content and labelling in 21 CFR 201.323. Aluminum concentration in large volume parenteral (LVP) medication products used in total parenteral nutrition (TPN) therapy shall not exceed 25 micrograms per litre (mcg/L), according to the law. The aluminium content restrictions of small volume parenteral (SVP) medication products and pharmacy bulk packages (PBPs) used in PN, on the other hand, are not set by legislation or regulation. Furthermore, the International Council for Harmonisation (ICH) has not defined a PDE for aluminium.
Source: https://www.fda.gov/media/163799/download
FDA published final guideline “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry”
Date of news: December 07, 2022
This guideline explains how we plan to prioritise enforcement and regulatory actions for homoeopathic medicine products marketed in the United States without FDA clearance. As explained further below, the FDA has devised a risk-based strategy through which the Agency plans to prioritise enforcement and regulatory actions concerning certain categories of such goods that may represent a larger risk to public health.
Source: Homeopathic Drug Products | FDA
News from MHRA “MHRA Added ‘Register of Electronic Export Certificates Issued by the MHRA (Human)”
Date of news: December 08, 2022
These documents provide information about all the electronic export certificates issued by the Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency (MHRA).
Source: Human medicines: register of electronic export certificates – GOV.UK
FDA published draft guideline “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers”
Date of news: December 09, 2022
The FDA is issuing this draught guidance to assist manufacturers in better understanding and implementing the Voluntary Summary Malfunction Reporting (VMSR) Program, which is an established voluntary programme in which manufacturers may submit certain malfunctions related to devices with specific product codes to the FDA in a summary format on a quarterly basis. The FDA’s VMSR Program is intended to benefit both the FDA and the public by increasing transparency for the public, assisting the FDA in processing certain malfunction reports efficiently, allowing both the FDA and the public to more easily identify malfunction trends, and reducing the burden on manufacturers. The purpose of this advisory is to explain, rather than modify, the terms of the VMSR Program.
Source: https://www.fda.gov/media/163692/download
FDA published draft guideline “Content of Human Factors Information in Medical Device Marketing Submissions”
Date of news: December 09, 2022
This draught guideline paper contains the FDA’s recommendations for human factors information that should be captured and included in medical device marketing submissions where such submissions are necessary. The guidelines are meant to increase uniformity and speed up the examination of medical device applications.
Source: https://www.fda.gov/media/163694/download
EDQM published post “How CEP holders can avoid the rejection of notifications”
Date of news: December 09, 2022
CEP holders are reminded that the EDQM Guideline on requirements for revision/renewal of Certificates of Suitability to European Pharmacopoeia Monographs lists different notifications and associated conditions, and that any change that is not classified as a notification or a major change should be classified as a minor change by default (with the exception of editorial changes for which specific guidance is given in the policy document). If the change cannot be classed as a notice by the document, a minor modification (by default) should be filed.
Members of the European Council endorse a plan to postpone MDR deadlines
Date of news: December 09, 2022
Members of the European Council voiced support for the European Commission’s proposal to postpone the transitional dates for medical devices under the Medical Devices Regulation (MDR). Members expressed concern that there is insufficient capacity to handle the thousands of outstanding conformity assessments that must be completed before the transitional period provided in Article 120(3) of the regulation expires, and they fear that if the current deadlines are not met, widespread shortages will result.
Source: https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf
