Drug Consulting and Orphan Drug Designations in Japan

The pharmaceutical companies researching and manufacturing various types of drugs invest huge infrastructure in manufacturing and researching them. The research and manufacturing of drugs require immense time. Apart from that the drugs need to go through series of tests and trials. After all these procedures, the drugs need to go through a series of regulatory channels to be ready for the market launch.

The world today is competitive and with the information technology in place, more and more competitors are gaining momentum in the markets. The markets, thus, are increasingly becoming even more dynamic where things change every smallest fraction of a second. In such a dynamic situation, the Japan orphan designation, pharmaceutical companies need to be even more cautious about the developments in the industry and the regulatory regime so that the company earns a profit after such a long gestation period of research and development.

It is difficult for a company to manage everything on its own and thus, a professional help in the form of required consultation can help the company gain major heights in the industry. The drug consultants provide this immense help. The consultants can either be professional individuals or a company who have proficient experience and updates about the latest happenings in the market. They provide timely consultations regarding all the facets of drug research, manufacturing and regulatory processes. From the beginning of the research to the trials and till the drug launch, the consultant can provide their expert opinions so that the companies can leverage the best out of their capabilities. They also provide their consultations regarding regulatory affairs and compliance, CRO regulation and management, and pharmacovigilance apart from providing inputs regarding the latest updates and development in the market.

Orphan Drug Designation in Japan

The orphan drugs are used to treat orphan disease. Such diseases are classified as rare diseases affecting only a few patients across the globe. The government needs to support the research and development of such drugs since the gap between the cost and return on cost is too high. Like other countries, Japan too has its own set of regulations. The Minister of Health, Labor and Welfare (MHLW) in consultation with the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) can classify a drug under the head of orphan drug only if it meets the required guidelines under Article 77-2 of the Pharmaceutical Affairs Law. 

The classification of orphan drug is based on certain criteria such as the drug would be used to treat only less than fifty thousand patient in Japan; such drug does not have an alternative available in the Japanese market or even if an alternative drug is available, the efficacy and safety standards met by the alternative drug is much lower than the drug in consideration; and many other such provisions. The orphan drugs are usually used to treat dreaded disesase and enjoy various incentives such as subsidy payments, guidance and consultation, preferential tax treatment, priority review and extension of re-examination period.