A comparison of European and Japanese pharmaceutical regulations : drug information and over the counter products perspective

Abstract

Background: Japanese and European Union (EU) regulatory bodies historically have in principle accepted regulations issued by each other and mutually agreed on the requirements and regulatory processes to provide drugs in a timely manner while ensuring safety, quality, and efficacy. However, there are still a number of pharmaceutical regulations in Japan and the EU which are different. Objectives: The aims of the study were to compare pharmaceutical regulations in Japan with those in the EU and identify differences and similarities between the two regulations. Methods: Pharmaceutical regulations related to drug information and classification of over-the-counter medication (OTC) were obtained from the websites of the Japanese and European regulatory bodies and journals. The pharmaceutical regulations of Malta, a European country, were used as an example for comparative purposes. The content and layout of the documents used for drug information were compared by reviewing regulatory guidelines for the preparation of each document or a sample of an actual document. Results: Two types of documents are mainly used as drug information references in Japan and the EU. Japanese Drug Information Sheet (DIS) and European Patient Information Leaflet (PIL) are intended for patient use. The Japanese Package Insert (PI) and European Summary of Product Characteristics (SmPC) are used by medical professionals. The DIS and PIL provide accurate drug information for patients, however, their publishers and contents are different. The DIS is issued by each pharmacy in Japan, tailormade for each patient, while the PIL is officially issued from industries. The PI and SmPC are similarly issued from industries and the information contained is confirmed by the regulatory authorities. The information within the PI focuses on providing cautions and warnings for safe use. Japan has classified OTC drugs into risk categories since 2009. OTC drugs are categorised as (i) Guidance-mandatory (GM) drugs, (ii) Type I, (iii) Type II, and (iv) Type III drugs by evaluating the extent of harmful impact on human health and the results of post-marketing surveillance. All OTC drugs can be distributed online, except for GM drugs. Type II and III drugs can be purchased without pharmacist intervention. In Malta, there is no classification within OTC drugs, and all pharmaceutical products must be dispensed only in pharmacies. Conclusions: Regulatory harmonisation between Japan and the EU does not extend to drug information documents and non-prescription medicines. There are differences in regulation in Japan and Malta. Harmonisation between Japanese and European pharmaceutical regulations can possibly be achieved through discussion and allowance for cultural differences.