An independent perspective on the East African Community Medicines Regulatory Harmonisation initiative

African regulators are taking bold transformative steps to optimise the effective and efficient use of their agency resources to assure access to quality, safe and effective medicines. In particular, [...]

2020-08-18T08:33:28+00:00August 18th, 2020|Tags: , |

Bujar et al 2020 – A Process for Evaluating Quality Decision-Making Practices

Background: The development of a medicine is not only underpinned by good science but also by Quality Decision-Making Practices (QDMPs). Indeed, it is important to ensure that all organisations [...]

2020-07-22T11:59:54+00:00July 15th, 2020|Tags: , , |

Rodier et al 2020 – Use of the CPP in 18 maturing markets

Background: The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing [...]

2020-07-08T09:03:16+00:00July 7th, 2020|Tags: , |

Keyter et al 2020 – Can standardisation of the Public Assessment Report improve benefit-risk communication?

Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used as [...]

2020-10-12T10:52:42+00:00June 18th, 2020|Tags: , , |

Bujar et al 2020 – Documentation of Quality Decision-Making Practices

Background: Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into [...]

2020-10-12T10:52:22+00:00June 18th, 2020|Tags: , |