Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Development of a new medicinal product containing a NCE intended for global marketing taking national regulations and requirements in the MENA region into consideration

Frauke Zeller, (geb. Tuchalski) (Abschlußjahr: 2011)

Language: English

When developing a new medicinal product, regulatory requirements will always have to be considered. Depending on the intended marketing activities post-approval, certain requirements must be taken into account in the early phase of the pharmaceutical development process. Medicinal products initially intended to be applied for marketing authorisation within the ICH region (Europe, USA and Japan) will strictly follow ICH requirements during pharmaceutical development. Nevertheless, as the main focus is being put onto the ICH regions but further countries the medicinal product shall be registered in may be considered later on. At a first glance, these countries may be of less importance but certainly, regulatory requirements established in these countries, that may deviate from the ICH regulatory requirements, also exist and most definitely have to be fulfilled when applying for registration.

In this thesis, regulatory requirements of the countries in the MENA region concerning Module 3 of the marketing authorisation dossier as well as administrative requirements such as company / manufacturer registration as well as Pricing have been discussed in detail, exemplarily for Jordan, Saudi Arabia and the GCC countries. Further MENA countries regulatory requirements and regulations have been introduced briefly in a separate chapter.

The MENA countries may be divided into countries requiring the comprehensive European registration file in its entirety, e.g. Saudi Arabia, GCC countries for the central drug registration; and countries that require only selected information in the registration files to be submitted, e.g. Jordan.

Dossier requirements established for the MENA countries can basically be considered in line with the dossier requirements established for the ICH region with only little amendments necessary for the MENA region. Nevertheless, the amendments required by certain MENA countries, e.g. Saudi Arabia may already be included into the European registration file as these requirements basically are of administrative character.

Nevertheless, important aspects of the regulatory requirements to be considered early in the development phase of a medicinal product concern the following:

  • Registration of a pharmaceutical company / manufacturer
  • Stability studies with climatic zone III / IV conditions
  • Halal compliance of raw materials used in the manufacture of a medicinal product.


At the end of this thesis, a brief introduction on the aspects to be considered in order to build up a regulatory strategy has been provided. Among these are the following:

  • Availability of a CPP
  • Establishment of a local affiliate or contracting a local agent
  • Duration of the registration procedures
  • Possibility of mutual recognition procedures
  • Advantages regarding e.g. participation on tender businesses etc.


Nevertheless, it is highly recommended to include countries outside the ICH region into the decision and planning phase for a new medicinal product in order to appropriately estimate the investment concerning costs and time necessary for the complete development and subsequent registration procedures in the intended markets. It is obvious that registrations in the main markets Europe, Japan, USA will be followed by markets with less priority, e.g. MENA region. Therefore, it is advisable to already include those low-priority countries into the decision and planning and, hence, take the corresponding regulatory requirements into account.

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