10. Regulatory Submission (Marketing Authorisation Application)

If the results of the Phase III clinical trials show an acceptable benefit-risk relationship, a Marketing Authorisation Application (MAA) can be prepared. All the information (non-clinical, clinical, and manufacturing) is collected and organised in a pre-determined format. This is called a ‘dossier’ and it is sent to the Regulatory Authorities. The expertise of the staff in the regulatory departments is very important as the different Regulatory Authorities around the world have (slightly) different requirements.

The International Council for Harmonisation (ICH) allowed many of the requirements for the USA, Europe and Japan to be harmonised. This has reduced duplication of testing and has simplified the process resulting in a Common Technical Document (CTD) for review.

Once the dossier is received, the Regulatory Authority will review the information and submit questions to be answered by the regulatory department staff (and other functions) of the company that submitted the MAA. Once the Regulatory Authority is satisfied with the results (risk-benefit), they will give their approval for the new medicine to be marketed. The review process usually takes 12-18 months. This period can be shorter in special cases agreed by the Regulatory Authorities, but can be prolonged if there are many questions to answer. The authorities may require more clinical trials before they are prepared to give their approval, and the medicine will not be allowed to enter the market until the Regulatory Authorities give their approval. Sometimes there are conditions that cannot be accepted by the Regulatory Authorities, and the medicine will not be approved to go into the market.

In many countries, Health Technology Assessment (HTA) is additionally performed by HTA bodies which give recommendations such as allowing the medicine to be prescribed and paid by the health system in the country.