Jouhou Koukai - New medicinal products approved in Japan in October 2003

October 8/15, 2003 - 17th NEW DRUG INFORMATION MEETING

The regular round of the New Drug Information Meetings series - organized quarterly by the Japanese regulatory authorities to better communicate the enforced and the expected regulations was held on October 8 and 15, respectively in Tokyo and Osaka with the following agenda:

Approval examination of new medicinal products
Progress with the revision of the Pharmaceutical Affairs Law (to be enforced in 2005)
Approval examination of pediatric medicines
Present situation with the examination of the matters concerning the reliability
About the guidelines for bioequivalency tests for generic topical skin application medicinal products

Synopsis of the key announcements at the meeting will be soon released by JKS.

	JKS Document Store		Tokyo, October 20, 2003
	JAPAN APPROVALS DATABASE The Japan Approvals Database (JAD) is the largest English-language database in the world containing information for all prescription medicines approved in Japan for the last 5 years (1999-2003) Visit JAD		New products approved in October 2003 On October 16, 2003 the Japanese regulatory authorities announced the approval of seven new prescription pharmaceuticals as the approval licenses were granted to totally 8 manufacturers. Two of the new holders ( Meiji and Wako) were granted approval for a jointly developed product, and one of the new holders (Aventis) was granted approvals for two new products. Click here to see the full list of the approved products. Note: The documents related to the approval of the above products - such as the Approval reviews or the SBAs are expected to be disclosed shortly. Further enquiries should be emailed to regulatory(at)jouhoukoukai.com.

	October 8/15, 2003 - 17th NEW DRUG INFORMATION MEETING The regular round of the New Drug Information Meetings series - organized quarterly by the Japanese regulatory authorities to better communicate the enforced and the expected regulations was held on October 8 and 15, respectively in Tokyo and Osaka with the following agenda: Approval examination of new medicinal products Progress with the revision of the Pharmaceutical Affairs Law (to be enforced in 2005) Approval examination of pediatric medicines Present situation with the examination of the matters concerning the reliability About the guidelines for bioequivalency tests for generic topical skin application medicinal products Synopsis of the key announcements at the meeting will be soon released by JKS. Enquiries: regulatory(at)jouhoukoukai.com