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

USA

Updated FDA Draft Guidance on Informed Consent

The FDA has released updated draft guidance aligning informed consent recommendations with the 2017 revisions to the Common Rule. The guidance emphasizes presenting essential clinical trial information clearly and in language patients can understand.

Final Guidance on Drug Volume Reporting

The FDA issued final guidance explaining how manufacturers and registered drug establishments should report the quantities of each listed drug that are manufactured, processed, or distributed commercially.

Industry Requests More Time for DSCSA Compliance

Stakeholders across the drug distribution supply chain continue expressing concerns that they will not be ready to comply with the enhanced Drug Supply Chain Security Act (DSCSA) requirements by November. Comments were submitted in response to the FDA’s proposed electronic tracking system, which applies to manufacturers, distributors, repackagers, and dispensers.

Final Guidance on Charging for Investigational Drugs

The FDA has issued final guidance on conditions under which sponsors may charge for investigational drugs used in clinical trials, along with updates to draft and product-specific guidances. The agency also extended the comment period for its guidance on master protocols.

Draft Guidance on Use of Data Monitoring Committees

Reflecting evolving practices, the FDA has published draft guidance updating expectations for Data Monitoring Committees (DMCs), including their roles, responsibilities, and use in clinical trials.

Stakeholder Concerns on Advanced Manufacturing Technologies Guidance

Industry groups, including the Alliance for Regenerative Medicine, argue that the FDA’s draft guidance on Advanced Manufacturing Technologies (AMT) may hinder innovation in cell and gene therapy by imposing restrictive requirements.

Draft Guidance Clarifies Drug Shortage Notification Requirements

The FDA has issued draft guidance explaining how and when manufacturers should notify the agency of interruptions or discontinuations affecting drugs, biologics, and active ingredients to help mitigate or prevent shortages.

EUROPE

ICH E2D(R1) Guideline on Post‑Approval Safety Data

The revised ICH E2D guideline clarifies definitions and standards for post‑approval individual case safety reporting (ICSRs). While based on the pre‑approval E2A guideline, E2D adapts these concepts for post‑marketing use. Technical details for transmitting ICSRs are provided in ICH E2B.

BANGLADESH

Required Documentation for IRB/IEC Approval

DGDA has published a list of documents required for IRB/IEC approval, including institutional information, IRB/IEC constitutions, focal person details, and terms of reference.

BELGIUM

Transition to Invoice‑Based Payment

Belgium is transitioning from advance-payment-by-provision to payment after invoice. Invoices will indicate whether provision balances are sufficient (“Provision OK”) or insufficient (“Provision NOK”). Applicants should refer to invoice numbers when submitting payments.

MALAYSIA

Updated Drug Registration Guidance Document (DRGD)

NPRA has issued the third edition, seventh revision of the DRGD, incorporating updates on packaging requirements such as shrink-wrapping and clarifying prohibited visuals and statements on labels.

Revised Biosimilar Registration Guidelines

NPRA has published the second edition of the biosimilar registration guideline, aligning with the WHO’s 2022 biosimilar guidance. Updates include enhanced clarity on quality, nonclinical, and clinical requirements, as well as pharmacovigilance and interchangeability expectations.

NETHERLANDS

Increased MEB Fees

The Medicines Evaluation Board (MEB) has increased fee rates for authorization applications, post‑authorization changes, and annual medicinal product fees. Consultation procedure fees have also risen.

PAKISTAN

New eAPP System Features for Online Drug Registration

DRAP has added new features to the eAPP system, enabling online submission of all drug product registration applications. This expands upon existing online licensing services.

Guidance on Pharmaceutical Unit Establishment and Post‑License Changes

DRAP has published the second edition of its guidance for establishing pharmaceutical manufacturing units and managing post‑license variations.

Updated GCP Inspection Guidelines

DRAP is revising its Good Clinical Practice inspection guideline to align with international best practices and incorporate stakeholder feedback.

SINGAPORE

Transition Plan for GMP Evidence for Drug Substance Manufacturers

HSA is implementing a phased plan to ensure full compliance with GMP evidence requirements for chemical drug substance manufacturers, aligning standards with those for biological substances.

Consultation on Patent Disclosure Requirements

HSA is seeking feedback on proposed changes to patent declarations required in therapeutic product registration applications. Applicants must disclose applicable patents and notify patent holders of submissions that may impact their rights.

SOUTH AFRICA

Post‑Recall Reporting Requirements

SAHPRA has issued guidance detailing the information required following a product recall, including urgency, nature of the defect, and actions taken.

Guideline on Medicine Recalls and Rapid Alerts

SAHPRA has released an updated guideline outlining processes for recalls, withdrawals, and rapid alerts to ensure product quality, safety, and efficacy.

SWITZERLAND

Updated Guidance on Product Information for Human Medicines

Swissmedic has released version 4.2 of its guidance on product information requirements for human medicinal products, providing clarification to support efficient processing.

Guidance on Variations and Extensions (HAM)

Swissmedic has also issued version 8.2 of its guidance on classification and submission requirements for variations and extensions to marketing authorizations.