01 Dec SAHPRA Accepted as a Member of the Worldwide Council for Harmonisation of Technical Necessities for Prescribed drugs for Human Use (ICH)
Embargo: Instant launch
Pretoria, 1 December 2025 – The South African Well being Merchandise Regulatory Authority (SAHPRA) has formally been accepted as a member of the Worldwide Council for Harmonisation of Technical Necessities for Prescribed drugs for Human Use (ICH), following an ICH evaluation of compliance with necessities for membership, together with a proper presentation outlining SAHPRA’s curiosity, progress, and milestones in implementing ICH rules.
The ICH is a novel world physique that brings collectively regulatory authorities and the pharmaceutical business to align scientific and technical requirements for the registration of medicines. Since its institution in 1990, it has advanced to help an more and more globalised pharmaceutical surroundings. Its mission is to advertise worldwide harmonisation to make sure that protected, efficient, and high-quality medicines are developed and registered effectively. This harmonisation is achieved by means of the event of ICH Tips, that are formulated by means of scientific consensus between regulators and business specialists. Profitable adoption depends closely on regulators’ dedication to implement these last Tips inside their nationwide methods.
The ICH Meeting met in particular person on 18-19 November 2025 in Singapore, in parallel with conferences of 12 Working Teams and preceded by conferences of the ICH Administration Committee (MC) and the MedDRA Steering Committee (SC).
“ICH is delighted to welcome NAFDAC, Nigeria, and SAHPRA, South Africa, as new ICH Members, along with two new Observers: DIGEMAPS, Dominican Republic, and Philippine FDA, Philippines, bringing ICH to a complete of 25 Members and 41 Observers.”
Welcoming SAHPRA’s membership, CEO Dr Boitumelo Semete-Makokotlela stated:
“This can be a important milestone for the South African Well being Merchandise Regulatory Authority. Membership of the ICH strengthens our dedication to the three pillars of security, high quality, and efficacy, whereas guaranteeing that our processes stay resource-efficient. This improvement permits SAHPRA to benchmark its regulatory practices towards world greatest follow for the advantage of all individuals dwelling in South Africa.”
Ms Silverani Padayachee, Senior Supervisor, Pharmaceutical Analysis Administration (SAHPRA) flanked by Chair of ICH Meeting Ms. Lenita Lindström (left) and Vice Chair Dr. Gabriela Zenhäusern (proper).
Obtain PDF
