The WHO-GMP is an international standard for drugs, representing the internationalization trend of GMP standards. Many developing countries have realized the benefits of this internationalization trend, especially in terms of the similarity and universality of documents and systems. As a result, many countries have directly accepted the WHO-GMP standard.
The WHO-GMP belongs to the technical framework for international drug trade and is a form of international cooperation. Its legal status depends on the attitudes and specific situations of the countries involved. If both parties agree to the WHO's protocol and method, GMP inspections are not required in bilateral drug trade.
The current version of the WHO-GMP was revised in 2003 and consists of four major parts: basic requirements, GMP for special drugs, GMP inspections, and supplementary guidelines. The WHO has used the inspection guidelines for European and American drug markets as a blueprint and has designated a pre-approval inspection guideline to recommend to its member countries.
The WHO-GMP plays an important role in the standardization of GMP practices for drugs worldwide. By adhering to the WHO-GMP standard, countries can ensure the quality of their drug products and improve their competitiveness in the global pharmaceutical market. Overall, the WHO-GMP is an essential tool for promoting public health and international cooperation in the pharmaceutical industry.