Good morning!
I am pleased to welcome you to the Green One UN House as you participate in the WHO workshop on the implementation of the guideline on procedures and data requirements for changes made to approved vaccines.
WHO supports the Member States in achieving better health for everyone, everywhere. This is what universal health coverage, or UHC, is about. Everyone should be able to obtain the quality health care services they need, when they need it, right in the heart of the community, without financial hardship.
In order to achieve UHC, people should have access to quality, safe, efficacious and affordable medicines and vaccines. For the next three days, we will discuss on universal access to quality and safe vaccines.
Both manufacturers and regulators have distinct and important roles to play in order to ensure quality and safe vaccines. Regulators set standards and procedures, and provide marketing authorizations to new vaccines to enter the market after proper clinical trials and reviews. Following the approval, manufactures make changes on production process, testing methods or product labeling information, in order to continue improving quality, safety and efficacy of the product. Regulation of post-approval changes, therefore, is one of the most important elements of vaccine regulation post marketing authorization.
In response to requests by Member States, WHO developed the Guidelines, TRS 993, on procedures and data requirements of changes to approved vaccines, with the evaluation of the data set to ensure quality, safety and efficacy of the product. The Guidelines also provide basic information to the authorities for the development of their own national guidelines. This will help timely access to the vaccines needed for their immunization programmes. The information in the Guidelines also provides vaccine manufacturers with the design of the studies to support the changes made. Furthermore, implementing the Guidelines serves as a basis for the harmonization of different national guidelines currently in use across countries.
Following the success of the first workshop in Thailand in 2015, we are very honoured to organize and host this three-day workshop with participation of around 50 participants from regulatory bodies and the manufacturing industries in 8 countries, including Viet Nam. We are quite fortunate to have global experts, together with my colleagues from the WHO Headquarters and the Regional Office, as facilitators for this workshop; they were key members of the drafting group when the Guidelines were being developed.
I sincerely hope that this workshop will help you better understand the key principles and expectations of regulation of post-approval changes. I look forward to this workshop providing a forum for NRAs and vaccine manufacturers to enhance their communications, as well as build mutual trust and confidence.
I wish you all three fruitful days of discussions. I hope you have a pleasant stay in this beautiful city.
Thank you.