Import Applications for Unregistered Medicines and Biomaterials in Russia

Legal entities in Russia can now apply for the import of unregistered medicines and biomaterials through the State Services portal. This online submission process simplifies and accelerates applications. The portal provides an electronic form for obtaining authorization to import specific batches of registered or unregistered medicines, including those intended for clinical trials or drug evaluations. Users may also remotely request permits for importing or exporting biological materials collected during clinical trials.

Sri Lanka – Notice to Importers and Local Manufacturers

All importers and local manufacturers must submit a hard copy of the Maximum Retail Prices (MRP) for medicines imported or manufactured as of 01.12.2022. A soft copy must also be emailed to the NMRA Pricing Unit at pricing@nmra.gov.lk within two weeks.

ICH M12 Guideline on Drug Interaction Studies

The ICH M12 guideline offers recommendations to harmonize the design, execution, and interpretation of enzyme- or transporter-mediated in vitro and clinical drug–drug interaction (DDI) studies. The guidance primarily applies to small-molecule therapeutic development.

EMA Begins First RWE Studies Under DARWIN EU

The EMA has launched its first real-world evidence (RWE) studies within the DARWIN EU initiative. Three initial projects mark the start of an accelerated program designed to strengthen regulatory decision-making using analyses from real-world healthcare databases. Erasmus University Medical Center Rotterdam serves as the coordination center for DARWIN EU.

EMA Safety Committee Recommends Withdrawal of Pholcodine-Containing Cough Medicines

EMA’s safety committee has recommended the removal of pholcodine-containing medications—used for dry cough and flu-like symptoms—from the EU market due to emerging safety risks.

FDA Finalizes ICH E19 on Selective Safety Data Collection

The FDA has issued final guidance supporting reduced safety data collection in late-stage and post-approval clinical trials when appropriate, aiming to improve trial efficiency without compromising patient safety.

ICH Endorses Continuous Manufacturing

A new ICH guideline promotes wider adoption of continuous manufacturing (CM), citing benefits such as reduced production time, fewer human errors, and improved overall quality.

FDA Issues Guidance on Bioequivalence Studies and Presubmission Correspondence

New FDA recommendations clarify how sponsors should apply equivalence criteria in bioequivalence (BE) studies. The guidance also outlines expectations for presubmission communication with the agency.

FDA Updates Statistical Approaches for Bioequivalence Assessment

A new draft guidance revises FDA principles for evaluating in vivo and in vitro bioequivalence for INDs, NDAs, ANDAs, and supplements. The update introduces considerations for narrow therapeutic index drugs, highly variable drugs, adaptive designs, and managing missing data.

FDA Updates Draft Guidance on ANDA Pre-Submission Facility Correspondence

The FDA has revised its guidance on pre-submission facility correspondence (PFC) under GDUFA III. To qualify for priority review, applicants must submit their PFC at least two months before filing an ANDA, PAS, or amendment.

FDA Advocates for Cloud-Based Regulatory Submissions

FDA leadership has emphasized the advantages of cloud-based regulatory assessment systems, which support more consistent product reviews. The agency’s modernization efforts align with ICH M4Q(R2), which aims to update CTD quality information standards.

Industry Requests Alignment of Pediatric Pharmacology Guidance with ICH Standards

Several industry groups have recommended that FDA align its updated pediatric clinical pharmacology guidance with international ICH guidelines and clarify key sections to reduce ambiguity.

FDA Draft Guidance on Aluminum Content in Parenteral Nutrition Products

The FDA has released draft guidance describing how manufacturers should measure aluminum levels in small- and large-volume parenterals to ensure parenteral nutrition products remain within recommended safety limits.

FDA Proposes Enhanced Annual IND Reporting Requirements

Two proposed FDA rules would require more detailed annual reports for investigational new drug applications (INDs) and outline exemptions for certain clinical studies involving foods, dietary supplements, or cosmetic products.