16 Jul 2019

Botswana Medicines Regulatory Authority (BoMRA) is expected to ensure that all medicines and related substances used in Botswana are in conformity with established criteria of quality, safety and efficacy, says Minister of Health and Wellness, Dr Alfred Madigele.

Speaking at the launch of BoMRA in Gaborone recently Dr Madigele said the authority should uphold standards for the regulatory functions value chain and ensure adherence to best practice.

He said the authority would ensure that health professionals and patients had the necessary information to enable them to use medicines rationally and also ensure that promotion and advertising were fair, balanced and aimed at rational drug use.

Dr Madigele noted that the objective of the regulatory mandate was to give Batswana assurance, hope and trust that all medicines, medical products, including complementary medicines distributed, manufactured and used in Botswana were safe, efficacious and above all of good quality and that they saved lives.

 “I am also informed that BoMRA is targeting to reach the World Health Organisation (WHO) Maturity Level 3 by 2024, where all eight core medicines regulatory functions, as defined by WHO, will be operational and meeting the criteria and standards set for level Maturity,” he said.

For his part the WHO representative in Botswana, Dr Martins Ovberedjo said the launch of BoMRA was underlined by the fact that quality clinical care required access to quality assured medical products including medicines, vaccines, blood and blood products, anti-venoms, medical devices and diagnostics.

He said striving to improve service delivery, emergency response, community outreach, infection prevention and control and curb antimicrobial resistance as health professionals, heavily relied on the timely availability of medical products.

Dr Ovberedjo reaffirmed the pivotal role and contribution of medicines regulators and efficient regulatory systems in ensuring access to good quality medicines and medical devices and stated that the regulatory profession was a meticulous day- to- day work that contributed to the appropriate functioning of the entire health system.

Assistant Minister of Agricultural Development and Food Security, Mr Kostantinos Markus said the ministry was excited with the formation of BoMRA and saw it as a landmark in the journey towards One World One Health, which the entire world had adopted in order to achieve better health and safer foods by the year 2050.

The ministry, he said found it proper to authorise BoMRA to manage veterinary medicines on behalf of the agriculture ministry as well as human medicines on behalf of the Ministry of Health and Wellness. Ends