As part of the agreement signed by all the ASEAN countries, the Philippines will begin to only accept dossiers submitted under the ACTD (ASEAN Common Technical Dossier) Guidelines. While submitting guidelines under ACTD has been allowed since 2007, most companies opted to register under the local Philippine guidelines as the number of examiners for the ACTD were few in number, resulting in delayed registration.
This step to only allow ACTD is in line with the other proposed changes in the Philippine FDA, including the recent decision to increase FDA fees in some areas by more than 1,000 %. The ACTD was scheduled along with the increase of fees to be implemented by July 1, 2013, however, with the recent resignation of Dr. Go the director of the FDA, the implementation of the ACTD and the fees has been delayed.
No final date has yet to be released by the FDA regarding the exact date of implementation although DOH Secretary Ona will be holding a conference next week with industry stakeholders to discuss the implementation.
Triple i Consulting is the only ISO:9001 2008 registered regulatory affairs specialist in the Philippines. Assisting both large mutli-national firms as well as small generic drug companies with the registration of food, drug, medical device, and clinical trials. For more information please feel free to contact us.