Table 1

Efficiencies for regulatory system strengthening in small states

EfficiencyDescription and benefits
  • Occurs when countries or organisations with similar characteristics (eg, histories, cultural values, languages, etc) form collaborations to accomplish regulatory functions, usually through economic integration mechanisms. In regulation of medicines, this can result in a single portal of entry that increases market size, reduces fragmentation of standards and enables countries to conduct regulatory functions collectively or through individual members performing functions on behalf of others.

Reliance (including recognition)
  • The act whereby the NRA in one jurisdiction may consider andgive significant weight to—i.e. totally or partially rely upon—evaluationsperformed by another NRA or trusted institution in reaching its own decision.17

  • Recognition, a form of reliance, occurs when a regulatory system adopts the decision of another trusted entity.

  • Relying on the work of other trusted regulators for regulatory functions (eg, marketing authorisation, inspections) may reduce staff workload and/or allow focus on other priority areas.

  • Requires that the product under review has to be exactly the same as the one authorised and oveseen by teh trusted authority, including place(s) of manufacture.

Fast-track/ accelerated reviews
  • Many regulatory authorities employ mechanisms to speed the processing of products deemed of high public health value. These can occur with a reprioritisation of resources and focus or can be the result of shortened reliance-based processes

  • Should not compromise product safety, efficacy or manufacturing quality standards.

Work sharing
  • A process, usually within the context of reliance, by which regulatory systems collaborate on regulatory activities such as assessing applications for marketing authorisation, joint work in postmarketing surveillance of therapeutic product safety, among others.

  • Benefits include conserving staff and time resources, pooling scientific acumen and regulatory expertise, and so on.

Information sharing
  • A process whereby information on a variety of regulatory activities is shared either publicly or confidentially.

  • It can be particularly helpful to share postmarket surveillance information among countries that have common products in their markets.

  • Digitising systems using commonly available software can provide benefits ranging from easier searching and organisation of records to decreased need for physical storage space.

  • Allows for digital submissions that can attract off-site and foreign manufacturers.

  • Use of a public website for the regulatory authority on the Ministry of Health webpage can be an inexpensive way to dramatically improve transparency and accountability, such as through publishing lists of approved products, licensed importers and enforcement actions.