Transparency is crucial for regulatory agencies. How does your agency ensure transparency in its operations?
Transparency is one of our core principles. We publish guidelines, regulatory decisions, and safety information on our website. We also provide public access to information on licensed medicines, including their package inserts and adverse event reporting processes.
That's commendable. Now, let's discuss compliance with international standards. How does your agency ensure that it aligns with global best practices?
We actively participate in international forums and collaborate with other regulatory agencies. We regularly review and update our procedures to incorporate the latest guidelines. We also undergo external audits and strive for accreditation to validate our adherence to international standards.
That sounds comprehensive. How do you handle situations where safety concerns arise post-licensing?
We have a robust pharmacovigilance system in place. We encourage healthcare professionals and patients to report any adverse events, and we closely monitor the safety profiles of licensed medicines. We take prompt action if any safety issues are identified.