Gulfstream Daily Brief

Regulatory intelligence and policy · Issue 042

Clinical trial systems, ICH M13B implementation, and safety updates

European regulators focused on clinical trial operations and bioequivalence implementation, while FDA opened a safety survey collection for comment and MHRA issued new safety updates.

By Scott Morvay, Founder October 29, 2026 Official sources linked

EMA

EMA addresses implementation of ICH M13B

EMA published considerations regarding implementation of ICH M13B on bioequivalence for immediate release solid oral dosage forms.

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EMA

EMA updates notice on clinical trial computerised systems

EMA published Revision 1 of its notice to sponsors on validation and qualification of computerised systems used in clinical trials.

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MHRA

MHRA publishes clinical trials hub

The hub brings together the UK legal framework, regulatory requirements, and guidance for designing, applying for, conducting, modifying, closing, and maintaining compliance in medicines trials.

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FDA

FDA seeks comment on rapid response surveys

FDA opened a 60 day comment opportunity on surveys intended to obtain safety information for quick turnaround decisions about potential safety problems or risk management solutions.

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MHRA

Specified Mynzepli batches recalled

Advanz Pharma Limited is recalling specified batches of Mynzepli 40 mg/mL solution for injection in prefilled syringes as a precautionary measure.

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FDA

FDA issues rare pediatric disease priority review voucher for ATEBRIOZ

FDA announced that ATEBRIOZ (zilurgisertib), approved September 25, 2026, met the criteria for a rare pediatric disease priority review voucher.

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FDA

FDA issues rare pediatric disease priority review voucher for EMCITATE

FDA announced that EMCITATE (tiratricol), approved September 28, 2026, met the criteria for a rare pediatric disease priority review voucher.

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Why this matters

The EMA and MHRA publications give regulatory teams new reference points for bioequivalence work, computerised system oversight, and UK clinical trial compliance. FDA's comment request provides an opportunity to inform how the agency gathers rapid safety information, while the recall and voucher notices require awareness across safety and regulatory intelligence functions.

Scott Morvay

Founder, Gulfstream Intelligence

This brief provides general regulatory news and educational information. It is not legal or regulatory advice.