Guideline for Development, Review and Approval of Regulatory Instruments

Regulatory authorities have a duty to ensure that they regulate in a manner that achieves public policy objectives. It is therefore critical that a coherent legal and regulatory framework is established and implemented to provide the required level of oversight while facilitating innovation and access to safe, effective and good quality medical products and professionals that are fit to practice.

The Pharmacy and Poisons Board (PPB) recognizes that effective regulatory systems are an essential component of health system strengthening and contribute to better public health outcomes and regulators are an essential part of the health workforce. Consequently, this Guideline has been developed to guide developers, reviewers and approvers of regulatory instruments to produce high quality regulatory instruments that meet the minimum Good Regulatory Practices (GRP) prescribed by the World Health Organization.

Similarly, it sets out the PPB Standards for Guidelines and provides stepwise advice on the technical aspects of developing a PPB guideline and the methods used. It aims to provide a clear path through the process and seeks to ensurethat the resulting guidelines have credibility and meet PPB’s criteria for content, methods and presentation, while remaining accessible and useful. Involvement of the public is the hallmark of a regulatory system that is responsive to its environment. This guideline therefore provides a framework for the conduct of public participation in development and implementation of regulatory instruments, taking into account the Constitutional requirements and the threshold set out in the Public Service Commission Guidelines for Public Participation in Policy Formulation.

The appropriate forms and templates have been attached as appendices at the end of the guidelines to ensure standardization of PPB regulatory instruments. We hope you will find this document beneficial in ensuring good regulatory practices and quality management systems at the PPB.

We undertake to review these guidelines and incorporate up-to-date practices, as may be necessary for our setting to achieve public policy objectives.