Pharma GMP News of the Week: 25-April-2023
Period: April 9, 2023 to April 22, 2023
FDA has published “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers”
Date of news: April 12, 2023
This guidance offers details on risk-based methods for observing how clinical trials for human drugs, biologicals, medical devices, and combination products are carried out. A quality control approach for assessing whether investigational activities are being carried out according to plan is clinical investigation monitoring. This advice includes suggestions for organising a monitoring strategy, creating a monitoring plan’s content, and dealing with and sharing monitoring outcomes. By adding further details to help sponsors execute risk-based monitoring, this guideline builds on the industry’s Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013) approach.
Source: A Risk-Based Approach to Monitoring of Clinical Investigations–Questions and Answers
FDA has published Draft Guidance for Industry on “Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs”
Date of news: April 12, 2023
“Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs” (Revision 2) is the name of a revised draft guidance for industry that the Food and Drug Administration (FDA or Agency) is stating is now available. The same-named draught guidance (Revision 1), which was published in the Federal Register on October 10, 2018, is revised by this draught guidance (Revision 2). This updated draft of the guidance offers suggestions for the planning and execution of studies assessing the effectiveness of transdermal or topical delivery systems (collectively referred to as TDSs) for adhesion. Applicants may decide to analyse TDS adhesion in studies carried out only to do so or in studies carried out with a mixed purpose depending on the goals of a generic TDS product development programme.
FDA has published “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs”
Date of news: April 13, 2023
The Food and Drug Administration (FDA or Agency) has made an updated draught guideline document for industry available titled “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.” This updated draught guidance offers suggestions for the planning and execution of studies to assess a proposed transdermal or topical delivery system’s (collectively referred to as TDS) potential for in vivo skin irritation and sensitization (I/S). The recommendations in this updated draught advice pertain to studies that are submitted in support of an ANDA. In vivo skin I/S studies are covered in the FDA’s guidelines and expectations, which are clarified in the revised drafting guidance. The October 2018 draught guidance titled “Assessing the Irritation and Sensitization Potential” has been updated by this guidance.
FDA has published “Over-the-Counter Monograph Order Requests: Format and Content”
Date of news: April 13, 2023
The goal of this advice is to help requestors create OTC monograph order requests (OMORs) that can be submitted to the FDA in accordance with section 505G of the FD&C Act (21 U.S.C. 355h). This guidance lists pertinent guidance materials to help requestors prepare their OMORs and offers FDA’s recommendations on the structure and information that requestors should include in them.
FDA has published “Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment”
Date of news: April 19, 2023
The Food and Drug Administration (FDA or Agency) is announcing the release of a new industry advice document titled “Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.” This draught guidance is meant to help sponsors and other interested parties develop medications to prevent or treat acute radiation sickness (ARS), which is brought on by exposure to ionising radiation from unintentional or intentional sources. Drugs created for these uses typically need to receive approval under the laws known as the “Animal Rule.”
EMA seeks public consultation on a reflection paper “Single-arm trials as pivotal evidence for the authorisation of medicines in the EU”
Date of news: April 21, 2023
The European pharmaceuticals Agency (EMA) has initiated a public consultation on a reflection paper with a PDF icon that addresses key ideas for single-arm clinical trials that are provided as crucial support for marketing authorization requests for pharmaceuticals in the European Union (EU). This is the first advice document from a global medical regulator outlining the factors and difficulties involved in conducting clinical studies of this nature. By midnight (CET) on September 30, 2023, stakeholders are requested to submit their opinions via an online form.
Source: Single-arm trials as pivotal evidence for the authorisation of medicines in the EU
Health Canada has published “Guidance on Nitrosamine Impurities in Medications”
Date of news: April 17, 2023
Health Canada gives its current opinions and suggestions in this guideline on N-nitrosamine impurities (also known as nitrosamine impurities or nitrosamines), but it reserves the right to change it when new information becomes available or as more applicants or market authorization holders (MAHs) need clarification.
Some medications and other items that include the nitroso functional group (-NO), which is recognised as a possible carcinogen, may have nitrosamine impurities, a form of chemical impurity.
Manufacturers must conduct risk analyses and implement the necessary controls to limit the possibility of nitrosamine generation, including employing diverse manufacturing procedures, acquiring materials from other vendors, and carrying out further testing.
Source: Guidance on nitrosamine impurities in medications | Health Canada
EMA has published Guidance “IRIS guide to Registration and Research Product Identifiers”
Date of news: April 20, 2023
The “IRIS guide to Registration and RPIs” was updated and made available by the European Medicines Agency last week (20 April 2023); it goes into great detail about the preliminary requirements for all IRIS submissions, including substance and Research Product Identifier registration.
The database known as IRIS—which stands for “Integrated Review and Information System”—is used by the European Medicines Agency (EMA) to oversee the evaluation of requests for marketing authorization of pharmaceuticals in the European Union.
During the evaluation process, the IRIS system offers a platform for communication and information sharing between the EMA and national regulatory bodies. The system is a safe, web-based tool for managing regulatory submissions, analysing data, and producing reports.
Source: IRIS guide to registration and RPIs v2.13
Malaysia NPRA published Guideline on “Electronic Labelling (E-LABELLING) for Pharmaceutical Products”
Date of news: April 11, 2023
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) published an updated version of its “Electronic Labelling (E-Labelling) for Pharmaceutical Products” guideline. This guideline is essential for ensuring that patients understand their treatments and for assisting HCPs in their decision-making.
The product information consists of labels, a package information booklet, and a summary of the product’s features, all of which are based on clinical development and post-marketing data. Both people and healthcare professionals (HCPs) are the target audience for these descriptions.
This paper serves as a roadmap for the adoption of voluntary e-labelling, and the Drug Control Authority must authorise the product information utilised.
Source: GUIDELINE ON ELECTRONIC LABELLING (E-LABELLING) FOR PHARMACEUTICAL PRODUCTS IN MALAYSIA April 2023
IMDRF published Guidance on CyberSecurity, Post-Market Surveillance, and Personalized Medical Devices
Month of news: April 2023
The IMDRF published four new technical guidelines, titled “Personalised Medical Devices – Production Verification and Validation,” “Principles and Practises for the Cybersecurity of Legacy Medical Devices,” “Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form,” and “Principles and Practises for Software Bill of Materials for Medical Device Cybersecurity.”
The International Medical Device Regulators Forum is a voluntary association of medical device authorities from different parts of the world who have gotten together to standardise the rules governing medical devices.
IMDRF encourages global cooperation and standardisation with the aim of enhancing the quality, safety, and efficacy of medical devices.
Personalized Medical Devices – Production Verification and Validation
Principles and Practices for the Cybersecurity of Legacy Medical Devices
Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity