Pharmaceuticals & Healthcare Bangkok Client Alert July 2015 www.bakermckenzie.com Bangkok 5th Floor and 21st-25th Floors 990 Abdulrahim Place Rama IV Road, Silom, Bangrak Bangkok 10500 Thailand © 2015 Baker & McKenzie. All rights reserved. Baker & McKenzie International is a Swiss Verein with member law firms around the world. In accordance with the common terminology used in professional service organizations, reference to a “partner” means a person who is a partner, or equivalent, in such a law firm. Similarly, reference to an “office” means an office of any such law firm. For further information please contact: Peerapan Tungsuwan +66 2636 2000 ext. 4334 firstname.lastname@example.org Prim Uditananda +66 2636 2000 ext. 4330 email@example.com FDA Implements the Licensing Facilitation Act: Adjustment of procedure for Clinical Trial Submissions As mentioned in our previous alert, a new law called the Licensing Facilitation Act goes into effect on 21 July 2015. Essentially, the law requires all government authorities to provide a licensing manual for the public and obligates the authorities to comply with the manual which spells out the rules, procedures, and conditions for the submission of the application, the work flow and timeline for granting licenses, and a list of documents required for the application. It also prescribes an official's duties and liabilities in this regard. In response to this Act, the Bureau of Drug Control under the Thai Food and Drug Administration (the "FDA") has issued an unofficial notification regarding the submission procedure for the clinical trial submission on a trial basis. According to the unofficial notification, there will be officials on duty at the One Stop Service Center located on the FDA premises on Tuesdays and Thursdays, commencing from Thursday, 2 July 2015 onwards, to check the completeness of applications and relevant documents to be reviewed by the drugs for clinical trial working group for the following types of application: 1. Permit to import drugs for research purposes (NorYorMor1) 2. Permit to import drugs for charitable purposes (NorYorMor4) in the case of distribution to private health facilities; 3. Permit to manufacture drug samples for drug registration (PorYor8) intended for research in humans; and 4. Permit to manufacture, re-package, or import placebos. It is our understanding that this is a temporary measure before the full guidelines in the manuals become official. In compliance with this act, the FDA aims to issue 237 manuals (54 for drugs, 40 for medical devices, 31 for food, 51 for narcotics, 15 for import-export inspection and 46 for cosmetics and hazardous substances). Most of the manuals have already been published on the FDA's website, with the remaining expected to be ready by 21 July 2015. However, the manuals are still in the draft version and may be adjusted after the trial period.