Tag Archives: China

The Global Standardization of Pharmaceutical Registration

16 Dec

The standardization of international pharmaceutical requirements started in the 1970’s as the European Community, now known as the EU, moved towards a single regulatory standard and market. At the same time, Europe, the United States and Japan discussed harmonizing the data requirements for registering pharmaceuticals.

Seeing the direction of global pharmaceutical registration, the pharmaceutical industry proposed a joint industry – regulatory authority initiative. By 1990, a global initiative had been set up under The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use or as commonly called the ICH.

The ICH Harmonised Tripartite Guidelines outlines the required administrative pharmaceutical registration documentation required specific to each nation or as the ICH calls them “regions.” ICH regions include Europe, China, Japan and the United States. The agreement harmonizes the registration requirements and standardizes required information such as information required on the registration form, required drug information and labeling.

An example of the use of ICH Harmonised Tripartite Guidelines in a specific ICH region is China’s drug
approval processes. In China, new drug applicants seeking China drug approval allows companies to register for a new drug application using a governmental form based on international pharmaceutical registration standards.

China’s standardized procedures are common international drug registration processes. They include a review of the drug application by the Provincial Drug Administration Authorities, who organize and handle the formal reviews of all application materials and samples to assure compliance with China’s drug policies.

Chinese experts experienced locally and internationally in medical treatment and pharmaceutical research conduct China’s drug evaluation reviews. China drug approval reviews include reports on similar international drug reviews, toxicology reviews, statistical data reviews, labeling, clinical reviews and safety reviews.

China’s material required for submission will seem familiar to many international pharmaceutical companies since they are based upon ICH guidelines. Required forms include documents for drug market access from the country of origin, drug review documentation from other regions, confirmation of drug ownership and patent information

China’s accordance to World Trade Organization agreements means that pharmaceutical patents and intellectual properties are protected. During the China drug approval process as in other international countries, new drug applicants should submit their patent information and certificate of ownership for the drug submitted. Once Provincial Drug Administration Authorities qualify a pharmaceutical company’s drug application, the application is then sent to the State Food and Drug Administration (SFDA) for further review and final approval.