Retrieval of documents related to medicinal products

Disclosure and retrieval

Primary information on medicinal products in Japan is available mainly from two sources - manufacturers or importers, and regulatory authorities. In limited cases, third parties - such as trade associations or patients group may provide secondary information - statistics, various data compilation, visual materials.
Predominant part of the information on medicinal products is made available online - either through public web sites (both governmental and non-governmental) or at various private or members-only services. Printed materials are also important where no digital sources are available.
With very few exceptions, all the information is in Japanese.

Information available from manufacturers and importers / trade associations
At present the manufacturers or importers or medicinal products - either by themselves or through third party information service providers, may make available information and documents indented to professional audience or general public. Examples of such disclosable information and documents are shown here. In most of the cases, the access to the information and documents intended for professional audiences requires registration and is provided as paid contents.

Information available from regulatory authorities
Key documents - such as the Approval Reviews (AR) are provided by the regulatory authorities - e.g. the Office of medicinal products to the PMDA, a designated review organization. The disclosure of regulatory documents is stipulated under the Public Access to Information Law (PAIL).
Requesting documents or information related to products of other makers is legal under the PAIL, however obtaining them might be objected to and issuance rejected on the ground of competitive issues. Under the PAIL those documents could be disclosed provided the Law for Prevention of Unfair Competition is not contradicted. Documents submitted for product approval may contain confidential information (manufacturing methods, description of technologies, know-how, patented data, data from non-clinical studies e.g. toxicology profiles) and gaining access by a third party to those data may provide a considerable competitive advantage, and hence fall under the restrictions of the laws for fair competition. As stipulated in PMSB Notification No 245, the application dossier may contain both formatted documents (documents prepared under certain standards for the content and form) and free form documents (attachments, appendices, letters). While the authorities have prescribed the mode for disclosure of the formatted documents, applicants for product approval bear the primary responsibility for designating those parts of the documents the disclosure of which may impair their legitimate interests. After certain negotiations, a consensus is achieved on how and what to disclose if the documents are planned to be published or provided to a third party upon requests based on the PAIL. Usually a compromise is reached with the issuance of partially blinded documents as shown here.

The Regulatory Group of JK Services provide support to international users in regard of basic information, document retrieval and regulatory data. Additional information and any further inquiries should be made by emailing to regulatory@jouhoukoukai.com.