SARAP – Slovak Association of Regulatory Affairs Professionals was established on 25 April 2002 in Bratislava, Slovak Republic. The Association has been included into the Slovak registry of legal entities with the effect from 15 May 2002.
It is a professional organisation gathering legal entities that are represented by regulatory affairs professionals/managers of different pharmaceutical companies both R&D and generic ones. The main aim of the Association is to support and protect the interests of its members focused on the drug regulation related activities.
SARAP is a non-profit organisation. The finances are covered only by member fees and potentially sponsor contributions. They are used for financing different educational activities (e.g. trainings, workshops, seminars).
SARAP has been established as a partnering professional organisation towards the national regulatory authorities, especially the State Institute for Drug Control, the MoH, the Institute of Public Health, Office of Industrial Property (Patent Office).
The establishment of SARAP was positively recognised by the SIDC. There have been several successful meetings and negotiations with the Slovakian HAs with positive impact on solving of the priority problems and transparency of the regulatory procedures.
Main focus on the following processes related to Regulatory environment:
- Product approval procedures and outcomes
- Manage and accelerate the registration approvals of medicinal products as a prerequisite for consequential pricing and reimbursement activities and product availability on the market
- Transparency and harmonisation of regulatory/registration processes
- Legislation support and participation in the implementation processes
- Intellectual property rights
- Solve the common problems on behalf of the regulatory community