Promoting Regulation of Medicines
There is no doubt that the pharmaceutical industry needs to be regulated according to agreed upon standards, policies and protocols. The regulations should also be consistent across the globe. Presently, regulation of the pharmaceutical industry varies greatly across the world. Some countries are semi-regulated, others are weakly-regulated and still others do not have any regulations at all. Every country should have a working national drug regulatory authority (NDRA). However, many developing countries face challenges such as weak regulatory systems, lack of regulatory capacity, inadequate regulatory framework, lack of funding, and inadequate legislation and policy. This leads to profound drug quality challenges.
Empower has done extensive work in pharmaceutical regulation globally. We have worked with various organizations like UN agencies (e.g., UNFPA, ADB), Ministries of Health (e.g., Haiti), and donor agencies (e.g., DfID) to promote consistent, appropriate regulations.
The drug regulatory framework focuses on policies and supporting structures that are essential for effective management of regulatory activities. The regulatory activities have been categorized into the following three focus areas: Product, Stakeholder and Consumer.
For more details, please see our projects in Pharmaceutical regulatory.