Tools for Effective Navigation: The World of International Drug Registration

There are many challenges in the world of international drug registration. Oftentimes, ineffective national drug registration systems lead to shortages in some countries of essential drugs manufactured abroad. Different regulations throughout the world can help to ensure that a drug is safe and is of proper quality; however, these same regulations can also act as a hindrance to providing a country’s population with critically needed medicines. Therefore it is imperative to stay up to date on international drug registration policies in different regions throughout the world and have access to ever-evolving resources that illuminate policies as they change in different countries and eventually provide greater medicinal access worldwide

Drug registration is the process by which a national or regional regulatory authority approves the use of a medicine in a particular country, having considered evidence of the medicine’s efficacy, quality and safety. However, there are substantial roadblocks to accessing international markets, particularly in some countries such as China, and therefore it is imperative to find information about changing policies abroad. These policies are continually evolving and can eventually provide better market access; however, there are still a number of obstacles. Because of this, it is essential to stay regularly informed on changing policies as they occur and there are several resources available to help.

One of the most informative resources is available via the World Health Organization (WHO). The WHO has promoted the idea that access to medicines, whether in developed or developing countries, depends upon effective regulatory bodies that ensure medicinal quality. However, many regulatory processes throughout the world are cumbersome and oftentimes delay entry of needed medicines, and usually in countries that have the greatest need. For example, China drug registration can be very complex since the Chinese pharmaceutical authorities control this process through extensive regulations. Market entry can thus be a challenge, and resource guides available through different private market research firms and international governmental bodies such as the WHO and the World Bank become essential in effectively navigating the China drug registration process, and in other equally challenging markets throughout the world.

Drug registration in different international markets can be a challenge today, but with access to the right resources that are becoming increasingly available, policy trends can be recognized and capitalized upon to ensure the continued broadening of markets worldwide.