Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Global Pharmaceutical Markets and the Influence of the International Organizations WHO and ICH ***

Karin Schöpf (Abschlußjahr: 2007)

Language: English

The international commerce of pharmaceutical products is increasing worldwide. Today the key markets are USA, Canada, some EU-countries, Japan, Australia and New Zealand. It is expected, that the increase of drug sales in China, Africa and Latin America will get higher in the next years. These emerging markets will get an important part in the global trade of pharmaceutical products. How can a country be prepared to have an effective regulatory system or how can it improve the existing system?

The international organizations WHO and ICH developed tools for a harmonized common regulatory system. Global acting pharmaceutical companies will find harmonized regulations for drug registration in many countries already. And the harmonization is improving due to the support of the WHO in many countries. The ICH work brings additional new and improved existing guidelines to the three ICH regions USA, Europe and Japan. But also non-ICH countries use the guidelines for their national registration system.

The benefit of the work of the international organizations WHO and ICH on regulatory harmonization is impressive. Global WHO databases for adverse drug reactions and for counterfeit medicines are helpful for the patients, pharmaceutical companies and regulatory authorities.

The ICH project to bring regulatory authorities and pharmaceutical associations of Europe, Japan and USA together to achieve harmonization in technical guidelines and requirements for drug registration was a great progress. The requirements for clinical trials, which are the most costly and time and resource consuming aspect in the development of a medicinal product were harmonized by ICH guidelines. These harmonized guidelines did also bring unified operating practices in the clinical trial process that increases the safety of the patients in the clinical trial. The ICH safety guidelines harmonized the pre-clinical toxicity testing, which brought a reduction in time and resources, but also a reduction in animals needed for tests, which is also an ethical aspect. ICH Quality guidelines mainly recommend the two areas of stability data and impurities. The harmonization of quality testing leads to one specification of a pharmaceutical product for the ICH regions, which makes the supply chain easier. The harmonized structure of the dossier for marketing authorization application leads to a time and resource saving dossier preparation and an easier review of the data by the authorities. The result is a faster time to market within the ICH regions.

Also if the economic aspect is important for a pharmaceutical company to bring their products on the market, the regulatory system in a country should not be the hurdle to gain marketing authorizations. The harmonization of the different regulatory systems will bring drug products faster on the markets for the benefit of the patients. And the pharmaceutical companies save time and resources with the harmonized registration systems.

The ICH Global Cooperation Group promotes the association of different harmonization initiatives to improve the worldwide harmonization of regulatory aspects, so that the global registration of pharmaceutical products will be even more easier and more effective in future.

Pages: 61,
Annexes: Pages:3