This chapter is intended for national authorities who are charged with authorizing the manufacturing, importation, marketing and control of antiretroviral medicines used for HIV prevention, whether for use as post- or pre-exposure prophylaxis (PEP or PrEP). The chapter is also intended to inform normative guidance from public health authorities and professional societies who are considering adopting WHO PrEP recommendations.
All medicines may have benefits and potential harms, which may be difficult for individual clinicians and clients to evaluate. As a result, most countries have developed processes for regulating the manufacturing, importation, marketing, and access to medicines. The exact regulatory pathways vary between countries.
Another chapter titled “Evidence to Decision” summarizes the systematic review and meta-analysis of PrEP that was commissioned by the WHO and performed between March and June 2015. This review covered PrEP effectiveness, safety, acceptability, feasibility, cost effectiveness, and equity. The evidence was reviewed by an independent expert review committee who endorsed the WHO recommendation in support of PrEP, which was approved by the WHO Guidelines Review Committee and published on 30 September 2015.
Chapter for Medicines Regulators (PDF) is coming. Contact us to request a draft.