Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Feb. 2024

USA

FDA Modernizes Informed Consent Guidance, Aligning With Common Rule Changes

The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand.

Final Guidance Details How to Submit Drug Volume Reports

A finalized FDA guidance outlines how drug manufacturers and all registrants of drug establishments should report the “amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution.”

Industry Needs More Time to Comply With Drug Supply Chain Security Requirements

Wholesale drug acquisition and distribution stakeholders say that even by November, the industry won’t be ready to comply with the Drug Supply Chain Security Act’s (DSCSA) updated security requirements. Comments from the industry were filed in response to the FDA’s electronic supply chain tracking proposal, which requires manufacturers, distributors, repackagers and dispensers to bring their systems into compliance with the enhanced drug distribution security requirements.

FDA Finalizes Guidance on Charging for Investigational Drugs, Takes Other Actions

The FDA has issued final guidance on charging for investigational new drugs in clinical trials, offering a minor update to its recommendations. In addition, the agency has published new draft and revised product-specific guidances and extended the comment period for its guidance on trial master protocols.

FDA Draft Guidance Modernizes Use of Data Monitoring Committees

With the composition, practice and utilization of data monitoring committees (DMC) changing considerably over the years, the FDA has published a new draft guidance on their use in clinical trials that will modernize its advice on the subject.

AMT Guidance Would Hinder Cell and Gene Therapy Progress, Commentators Charge

The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) pathway would be restrictive to manufacturers in the cell and gene therapy spaces, the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy said in filed comments.

Notification Process for Drug Shortages Explained in Draft Guidance

The FDA has issued a draft guidance on how and when applicants and manufacturers should provide information on interruptions or discontinuations of drugs, biological products and active pharmaceutical ingredients to help the agency prevent or mitigate shortages.

EUROPE

ICH E2D(R1) Guideline on post-approval safety data: definitions and standards for management and reporting of individual case safety reports

The ICH E2D guideline provides guidance on definitions and standards for post5 approval individual case safety reporting, as well as good case management practices. This 6 guideline was originally based on the content of the ICH E2A guideline (which provides guidance 7 on pre-approval safety data management), with consideration as to how the terms and definitions 8 should be applied in the post-approval phase of the product life cycle. Detailed guidance on the 9 specific structure, format, standards, and data elements for transmitting Individual Case Safety 10 Reports (ICSRs) is provided in the ICH E2B guideline.

BANGLADESH

List of documents required for IRB/IEC approval from DGDA

DGDA published list of documents required for IRB/IEC approval.  Name of Institution, Memorandum of article/constitution of IRB/IEC, Focal person’s Name, Designation and Contact Information, TOR (Terms of Reference) of IRB/IEC are some of the documents required.

BELGIUM

Transition from payment by provision to payment after invoice

Payment by provision is coming to an end. payment will be issued upon receipt of the invoice.

• If your provision balance is still sufficient to cover an invoice, “Provision OK” will appear on the invoice.
• If your provision balance is insufficient, “Provision NOK” along with the remaining provision balance will appear on the invoice.

Please pay the remaining amount of the invoice, referencing the invoice reference when making the payment. Note that the words sufficient/insufficient are only an indication as the data may vary due to payments, invoice creation and credit notes.

MALAYSIA

Drug registration guidance document

NPRA published DRGD, third edition, seventh revision. Shrink wrapping, packaging are added in product registration process. Additional information is added in prohibited Visual / Graphics / Statements on Label.

Guidance Document and Guidelines for Registration of Biosimilars in Malaysia

NPRA published Guidance Document and Guidelines for Registration of Biosimilars, second edition. This revision is primarily intended to align with the current edition of the WHO biosimilar guideline, published in 2022. The key changes include providing more clarity and details in terms of quality, non-clinical, and clinical data requirements, including updates on pharmacovigilance, interchangeability, and labelling.

NETHERLANDS

MEB fee rate change

The Medicines Evaluation Board (MEB) increases the fee rates for authorisation applications, authorisation changes and the annual fees of human medicinal products. Fees for consultation procedures will also be increased.

PAKISTAN

New features in eAPP system enabling Online Submission for all types of Registration Applications of Drug Products

DRAP added New features in eAPP system enabling Online Submission for all types of Registration Applications of Drug Products. The Drug Regulatory Authority of Pakistan (DRAP) added a new e-service for online regulatory data submission for registration/marketing authorization of human drugs for local manufacturing, import and export. This e-service complements the existing one for licensing operations of all pharmaceutical and biological manufacturers, which are both accessible through the same platform.

Establishment of Pharmaceutical Unit and Post License Changes

DRAP published Establishment of Pharmaceutical Unit and Post License Changes, second edition. This document is applicable to any applicant/firm/company who intends to establish a new pharmaceutical unit and for approval/endorsement of post license variances.

Guidelines on Inspection of Good Clinical Practices for Clinical Trials

The Drug Regulatory Authority of Pakistan (DRAP) is planning to revise its guideline for the conduct of Good Clinical Practice (GCP) inspection and reporting. The revision aims to update the guideline in accordance with the latest international standards and best practices, as well as to address the feedback and suggestions received from the stakeholders.

SINGAPORE

Guidance on the Implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers

the Health Sciences Authority (HSA) will roll out a transition plan for companies to fully comply with the requirement for Evidence of Good Manufacturing Practice (GMP) Compliance of Chemical Drug Substance (DS) manufacturers. This will align the GMP requirements for both chemical and biologic DS manufacturers. The full implementation of the GMP requirements for all DS manufacturers will enable companies to better assure the quality of therapeutic products supplied in Singapore for use in our patients.

Planned changes to rules on disclosing patents in filings

Singapore’s Health Sciences Authority (HSA) is inviting feedback on proposed changes to patent declarations in registration applications. Regulation 23 of the Health Products (Therapeutic Products) Regulations requires HSA to consider whether a patent is in force when it is assessing registration applications. The applicant must provide a patent declaration and tell the patent proprietor if a submission affects their intellectual property. The mechanism is intended to quickly resolve potential patent disputes.

SOUTH AFRICA

Post Recall Information/FINAL REPORT to SAHPRA

SAPHRA published Post Recall Information. It includes what information should be submitted to SAPHRA after recall of products. Post recall information included urgency of action taken, reason for action, name of defect etc.

Guidelines for Medicine Recalls – Withdrawals and Rapid Alerts

SAPHRA published Guidelines for Medicine Recalls. This guideline has been prepared to serve as a recommendation to applicants regarding the recalls and withdrawal of medicines, and the South African Health Products Regulatory Authority on the safety, quality, and efficacy of medicines.

SWITZERLAND

Guidance document Product information for human medicinal products

Swissmedic published ZL000_00_027, version 4.2. This guidance document describes the requirements for product information for human medicinal products and is aimed primarily at administrative bodies. For applicants, the document is intended to clarify the specific requirements that must be fulfilled so that the product information texts can be processed as quickly.

Guidance document Variations and extensions HAM

Swissmedic published ZL300_00_001, Version 8.2. This guidance document explains the requirements pertaining to variations and extensions for human medicinal products.