The globalisation of the rapidly developing healthcare technologies requires a joint effort by the national regulatory authorities (NRAs) to ensure that patients all over the world obtain early access to safe, high-quality medicinal products. One approach to accelerating access to safe, effective and high-quality medicinal products is to employ “reliance” and in so doing to exchange knowledge and make use of synergies.
The World Health Organization (WHO) defines “reliance” as an act whereby a national regulatory authority in one jurisdiction may consider and give significant weight to evaluations performed by another authority or trusted institution or other relevant information in reaching its own decision. The relying authority remains independent, responsible and accountable for decisions taken even when it relies on the decisions and information of others.
The use of “reliance” is embedded in the strategic objectives of Swissmedic. Swissmedic relies on the outcome of evaluations performed by partner authorities in its assessment of applications submitted according to Art. 13 and Art.14 of the Therapeutic Products Act (TPA), for example.
ICMRA calls on the NRAs, the World Health Organisation and the pharmaceutical industry to work together and make efficient use of the concept of “reliance”.
The full statement (in English) is available at: