Regulation of post approval changes to vaccines
Regulation of post approval changes or change control, is one of the most important key elements of regulation of vaccines by the national regulatory authorities. Changes, also refer to variations in other document, to vaccine composition, manufacturing process, quality control, equipment, facilities or product labelling information often happen after a vaccine has been approved. These changes may be made for the purpose of maintaining routine production, improving the quality attributes or improving the efficiency of manufacture or updating product labelling information. Any change to a licensed product may impact on the quality, safety and efficacy of the product and any change to the information associated to the product may impact on the safe and effective use of the product. These changes can be categorized as major, moderate and minor changes, depending on the potential of impact on the quality, safety and efficacy of the product and different regulatory approaches should be applied to guarantee the adequate regulatory oversight and different supporting data are needed to demonstrate and confirm the comparability of the “new” product manufactured with changes to the licensed product.
WHO has been frequently requested by the regulators of WHO member states on what regulatory approaches shall apply to these changes to assure the quality of the product and what studies shall be performed by the manufacturer to confirm the comparability. Based on the request WHO developed the Guidelines for procedures and data requirements for changes to approved vaccines and it was adopted by the Experts Committee on Biological Standardization (ECBS) in its meeting in 2014.
Written Standards
Guidelines on procedures and data requirements for changes to approved vaccines, TRS 993, Annex 4