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Drug safety governance framework

We have systems in place throughout GSK to collect adverse events on our products, follow-up with the reporter where necessary, transmit the adverse event data to the central safety departments, forward appropriate reports to the regulatory authorities and evaluate the safety data. We also have a policy requiring all GSK staff to immediately report any issues relating to the safety or quality of our medicines. See Employee guide to business conduct for more details.

Three central departments have responsibility for recording, investigating and evaluating adverse events and reporting these to the relevant regulatory authorities (eg the FDA or the European Medicines Evaluation Agency). These are our:

• Global clinical and safety pharmacovigilance team (GCSP), part of GSK Research & development, responsible for the safety evaluation of all our pharmaceuticals and devices.
• GSK Biologicals clinical safety and pharmacovigilance department, part of our vaccines business, responsible for the safety evaluation of GSK vaccines.
• Consumer Healthcare product safety group, part of our consumer healthcare business, responsible for the safety evaluation of Consumer Healthcare products.

Each country manager is responsible for ensuring the collection of safety information and reporting this to the relevant central safety department (as described above) and to the local regulatory authority.

We also have global labelling committees that review and approve the prescribing information for all our products and ensure this is updated when appropriate.

We have two Global safety boards, one for pharmaceuticals and vaccines and the other for Consumer Healthcare products. The Global safety boards are made up of senior GSK doctors and external consultants and their role is to advise and make decisions on the appropriate course of action regarding potential human safety issues.

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