The pharmaceutical industry is a considerably regulated branch, which means that obtaining marketing authorisation for medicinal products in any country is a lengthy and complex process. The process of obtaining marketing authorisation varies from country to country, depending on national legislation and guidelines. Understanding the differences in the process of obtaining marketing authorisation has a significant impact on the success of the company’s marketing strategy for an individual product; therefore, the focus of this thesis is an overview of marketing authorisation procedures, marketing authorisation being a prerequisite for marketing a product on a particular market. In the thesis, a comparison is made between medicinal product regulations on the EU markets and those on specific Asian and African markets (Singapore, Malaysia, Saudi Arabia and South Africa). The latter markets are becoming increasingly interesting for the pharmaceutical industry due to the increasing competition and a consequent gradual decline in the prices of medicinal products on these markets.
In the introduction, there is a general overview of the legislation and competent authorities by individual regions. Then, the process of obtaining marketing authorisation on individual markets and the specific requirements of the markets are reviewed through expert literature. The main focus is on new submissions for generic medicinal products, partly also on renewals and variations during a product’s lifecycle. A comparative analysis of the guidelines and requirements for obtaining marketing authorisation was made and it showed that the above-mentioned Asian and African countries are already highly regulated and have similar documentation requirements, which is logical, as they largely follow EU regulations and guidelines (e.g. CTD/ACTD format, classification of variations). The biggest differences are seen in the time of obtaining marketing authorisation (a well-defined timeline only in the EU), the validity of marketing authorisation (unlimited validity of marketing authorisation already upon first registration in Singapore and South Africa) and in the labelling of medicinal products (e.g. Braille mandatory only in the EU).
What is needed for appropriate documentation to be prepared and consequently marketing authorisation to be obtained within the set time frame is accurate knowledge of regulatory procedures and constant monitoring of the legislation.
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