List of Cosmetic Manufacturers in QUEST System in Malaysia
Review and verify that any cosmetic products sourced or distributed comply with the manufacturers listed in the updated QUEST system.
EMA established that draft protocols for non-interventional imposed PASS should now be submitted in Module 1.8.2 and aligned submission timelines for assessments are defined as 74 days for PRAC review and 67 days for EC decision.
MAHs need to adjust their planning and submission processes to comply with these updated timelines and requirements, which could significantly impact the speed of study implementation and monitoring of safety signals.
MAHs must ensure draft protocols are placed correctly in the CTD and that submission planning considers the clarified assessment timelines, with RMP updates contingent upon PRAC endorsement.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Updated Question 11 clarifies that the assessment of a non-interventional imposed PASS final study report by the PRAC takes up to 74 days, followed by 67 days for the European Commission decision-making process. Updated Question 12 specifies that draft protocols for these studies should be submitted in Module 1.8.2 of the CTD and only included in the RMP once endorsed by the PRAC.
MAHs must align their submission planning for non-interventional imposed PASS with the clarified assessment timelines. Draft protocols must be correctly placed in the CTD (Module 1.8.2) and RMP updates should only occur after PRAC endorsement.
Need for marketing authorisation holders to adapt to updated submission timelines and protocols
Change in submission requirements for PASS
MAHs must ensure draft protocols are placed correctly in the CTD and that submission planning considers the clarified assessment timelines, with RMP updates contingent upon PRAC endorsement.
The European Medicines Agency (EMA) has updated its guidance for marketing authorisation holders (MAHs) regarding non-interventional imposed post-authorisation safety studies (PASS). New assessment timelines for clinical protocol submissions include a maximum of 74 days for PRAC review, followed by 67 days for European Commission decision-making. Draft protocols must now be submitted in Module 1.8.2 of the Common Technical Document (CTD), and updates to risk management plans (RMP) should occur only after PRAC endorsement.
What changed: EMA established that draft protocols for non-interventional imposed PASS should now be submitted in Module 1.8.2 and aligned submission timelines for assessments are defined as 74 days for PRAC review and 67 days for EC decision.
Why it matters: MAHs need to adjust their planning and submission processes to comply with these updated timelines and requirements, which could significantly impact the speed of study implementation and monitoring of safety signals.
Practical implication: MAHs must ensure draft protocols are placed correctly in the CTD and that submission planning considers the clarified assessment timelines, with RMP updates contingent upon PRAC endorsement.
Published from the Firecrawl policy change extraction pipeline.
Review and verify that any cosmetic products sourced or distributed comply with the manufacturers listed in the updated QUEST system.
Annual reviews of new information will be conducted to update the summary, requiring continuous monitoring and data submission in response to findings.
Marketing authorization holders (MAHs) must review and potentially update their product labeling to align with the new regulations by 11 April 2029 for products authorized before 11 May 2024.
Regulatory Intelligence leads should initiate monitoring of feedback and prepare for potential regulatory adjustments related to the specified substances.