RAPS introduces expanded competency framework and evaluation tool

The Regulatory Affairs Professionals Society (RAPS) has rolled out an updated addition to its 2021 Regulatory Competency Framework, titled the Performance Criteria Addendum. This release is accompanied by a new tool designed to assess regulatory professionals’ performance. According to Lindsey Summers, MBA, vice chair of the committee behind the addendum, the criteria are intended to support organizations in recruiting, developing, and evaluating regulatory talent amid a rapidly evolving global workforce.

WHO demands urgent response after contaminated medicines linked to hundreds of child deaths

The World Health Organization (WHO) is urging regulators to act swiftly and in coordination after tainted cough syrups were associated with the deaths of more than 300 children in Indonesia, Uzbekistan, and other countries. WHO has issued multiple global alerts regarding poor-quality liquid formulations. Although the earliest incidents occurred in The Gambia, investigations traced the quality failures to manufacturers in Asia, including firms based in India.

NPRA revises Drug Registration Guidance Document (DRGD)

Malaysia’s NPRA has released the third edition, fourth revision of the DRGD. The update revises full and abridged review processes, fees, priority review pathways, API regulatory oversight, and requirements related to labelling and licensing.

PMDA updates Good Clinical Practice standards

Japan’s PMDA has issued a ministerial ordinance outlining updated Good Clinical Practice requirements, including new standards for trial oversight, execution, documentation, and sponsor obligations.

New guidance on conditional authorization applications

Turkey’s Medicines and Medical Devices Agency has issued guidance defining the application and review process for emergency-use conditional marketing authorization.

Guideline for renewing medicinal product registrations

The agency also released an updated framework describing procedures for license renewal of human medicinal products.

Medsafe refreshes guidance for new and changed medicines

Medsafe has updated its high-level overview of the regulatory process for new or modified medicines, adding instructions for electronically submitting applications and supporting documentation via its secure file transfer system.

NMA guidance for lower-risk medicines

A new guide has been issued to help applicants prepare New Medicine Applications for lower-risk products, including application categorization and formatting steps.

Updated guideline on therapeutic product regulation

Medsafe has also released a comprehensive guideline detailing application pathways for medicines across risk categories, including those referencing approved patented products and those eligible for priority assessment.

New requirements for evaluation of substances in listed medicines

The Therapeutic Goods Administration (TGA) has implemented mandatory submission requirements for applications to amend the Permissible Ingredients Determination under section 26BD. These requirements apply to new applications from 1 February 2023 and outline the data and documentation necessary for an application to advance to the evaluation stage.

EMA adopts ICH Q13 on continuous manufacturing

The European Medicines Agency is the first regulatory authority to implement ICH’s Q13 guideline on continuous manufacturing of drug substances and final products, which becomes effective on 10 July 2023.

EMA updates application instructions for certificates of medicinal products

EMA has issued an updated version of its application instructions for obtaining certificates of medicinal products. Only the newly issued form is accepted, and all submissions must include complete Parts A and B, along with supporting composition statements and MAH authorization where required.

Swissmedic revises decentralized clinical trial recommendations

Swissmedic, together with swissethics, has updated its position paper on decentralized clinical trials (DCTs). While the revised document acknowledges ongoing regulatory and legal obstacles, it emphasizes the agencies’ intent to encourage innovation in Swiss clinical research.

Revisions to guidance under Art. 13 TPA

Swissmedic has expanded the scope of temporary authorization under Article 13 TPA. The pathway now applies not only to products containing new active substances but also to new indications for known active substances. Portions of the former Q&A document have been incorporated into the updated guidance.

Changes to fast-track and temporary authorization procedures

Key updates include an extended deadline for submitting final decision minutes after AAA hearings and the activation of eGov portal functionality for document exchange. The revisions are effective immediately.

CTIS transition insights from experts

Industry specialists report that many companies are delaying Clinical Trial Information System submissions due to technical uncertainties and the need to provide both confidential and public versions of documents.

EMA confirms CTIS transition timeline

EMA has reaffirmed that CTIS will become mandatory for new applications at the end of the month, asserting that the remaining critical technical issues will be resolved before full implementation.

FDA draft guidance for acromegaly therapy development

FDA’s newest draft guidance advises sponsors to examine dose–response and exposure–response relationships early in development using IGF-1 as a key biomarker.

ICH releases final Q9(R1) quality risk management update

The finalized Q9(R1) guideline introduces additional clarity on risk analysis approaches, risk‑based decision-making, and handling subjective assessments.

FDA outlines lessons learned from QMM pilot assessments

FDA staff reported that pilot programs evaluating quality management maturity showed the need for streamlined scoring methods and pre-assessment briefings. These insights will guide further development of the QMM program.

FDA maintains existing orphan drug exclusivity approach

After reviewing recent legal challenges, FDA will continue linking orphan drug exclusivity strictly to the approved indication, reaffirming its stance following issues raised in the Catalyst Pharmaceuticals Firdapse case.

WHO pushes for removal of contaminated cough syrups

WHO continues calling for rapid removal of toxic cough syrups from markets and urges broader surveillance measures, such as targeted analytical testing.

CDER: QMM scoring proposal overly complex

CDER’s evaluation of its proposed scoring model concluded that the system is too complicated and needs simplification.

FDA: Oncology dose escalation should not default to MTD

New draft guidance recommends evaluating a broader range of doses rather than routinely escalating patients to the maximum tolerated dose.

FDA finalizes standardized REMS structure guidance

Two final guidances define a uniform structure and SPL-ready format for REMS documents to improve clarity and regulatory consistency.

FDA draft guidance on dosage and administration labeling

FDA’s new draft describes expectations for presenting dosage ranges, risk‑based adjustments, and administration instructions in product labeling.

ICH issues draft guideline for bioequivalence studies of oral drugs

The draft guideline describes design and participant selection considerations for bioequivalence studies of immediate-release oral dosage forms.

Experts highlight ongoing challenges with real‑world evidence

At the CERSI Summit, panelists cited persistent barriers to broader RWE use, including suboptimal data quality and mismatched clinical endpoints across settings.

CDER emphasizes simplified clinical trials to improve diversity

CDER Director Patrizia Cavazzoni encouraged sponsors to streamline trial protocols and consider alternative designs to better reach underrepresented populations.

Industry seeks more flexibility in pediatric growth measurement guidance

Stakeholders requested clarification and questioned whether a 12‑month observation window is sufficient for assessing pediatric growth parameters.

Stakeholders ask FDA to refine expanded access guidance

Industry groups asked FDA to further clarify pediatric eligibility, required response timelines, and provisions related to medical devices under expanded access.

Concerns about extrapolating adult data to pediatric populations

Experts cautioned that FDA’s draft guidance may place too much weight on adult data, emphasizing the need for child‑specific evidence in ethically appropriate trials.

Industry comments on ICH Q5A(R2) highlight need for continuous manufacturing guidance

Pharmaceutical groups supported the guideline but urged additional clarification on viral safety considerations for continuous manufacturing processes.

Requests for harmonization in human subject protection regulations

Commenters called for streamlined informed consent requirements and better alignment between FDA regulations and the revised Common Rule, particularly regarding single‑IRB review for multisite studies.