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Consultation overview
Current regulatory consultations
Find selected regulatory consultations from FDA, EMA, and other relevant authorities in one structured overview. Track open topics, key deadlines, and consultation details to support timely internal assessment and response planning.
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Philippine FDA Consultation on Modes of Regulatory Inspection for Food and Drug Administration Regulated Health Product Establishments
The Philippine Food and Drug Administration (Philippine FDA) has published a draft Circular for comments on Modes of Regulatory Inspection for Food and Drug Administration Regulated Health Product Establishments. The draft proposes a risk-based framework for determining whether regulatory inspections should be conducted on-site, remotely, or using a hybrid approach, while retaining on-site inspection as the primary mode.
FDA Consultation on Robotically-Assisted Surgical Devices – Premarket Submissions
On 25 September 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on Robotically-Assisted Surgical Devices – Premarket Submissions. The draft provides recommendations on premarket submission content, non-clinical testing, clinical evidence and labeling for certain robotically-assisted surgical devices (RASDs). It is intended to promote greater consistency in the information provided to FDA and facilitate the review of these complex systems.
FDA Consultation on the Electronic Submission Template for Premarket Approval Applications (PMAs)
On 18 September 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance on the Electronic Submission Template for Premarket Approval Applications (PMAs). The draft describes FDA’s proposed approach to the electronic submission of specified PMA application and supplement types using the electronic Submission Template And Resource (eSTAR).
MHRA Call for Evidence: Beyond ADMET: AI for Medicines Safety
On 22 September 2026, the Medicines and Healthcare products Regulatory Agency (MHRA), together with the Regulatory Innovation Office (RIO), opened a call for evidence on the use and development of artificial intelligence (AI)-based approaches for medicines safety evaluation. The survey seeks information on current and planned uses of AI, as well as barriers and challenges relating to model development, validation, data access, data sharing and regulatory considerations.
FDA Discussion Paper on Considerations for the Regulation of Generative AI-Enabled Medical Devices
On 18 August 2026, the U.S. Food and Drug Administration (FDA) issued a discussion paper seeking early stakeholder input on potential approaches to the regulation of generative artificial intelligence (GenAI)-enabled medical devices. Importantly, this is not a regulatory consultation on draft guidance or proposed policy. Rather, FDA is using the discussion paper to seek early stakeholder feedback and inform CDRH's ongoing consideration of regulatory approaches.
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