SAU MCI consulted on updating the guidelines re Good Pharmacovigilance Practices.
Ensure safety, quality, efficacy of registered and marketed pharmaceutical products.
Key Provisions
Concerns stages of products from their development to post-marketing surveillance.
Mitigate the risks associated with medicinal products while enhancing public health outcomes for individuals through availability and use of safe and effective treatments.
Ensure pharmacovigilance measures implemented compliance with global practices.
Required MAH to submit SSA whenever EU RMP (or alternative RMP where no current EU RMP exists) is submitted in pre-marketing during registration and post marketing.
Applicant shall submit RMP describing risk management system, with a summary.
SFDA may issue additional safety announcement, and disseminate DHPC to healthcare professionals’ organizations if several marketing authorization holders are concerned.
Required to take necessary actions in line with suggestions received from regulatory authority/health authority mentioned in WHO-WLAs and have vigilance function listed.
Effectiveness
Comments must be provided between Mar. 23, 2025 and Apr. 30, 2025.
