REGULATORY REQUIREMENTS FOR THE APPROVAL OF ANTI-CANCER DRUGS IN PHILIPPINES AS PER ACTD

Ashok Kumar P.*, Keerthirani S., Manoj C.K., Rashitha V., Moka Nataraj Nithin and Inchara K.P.

ABSTRACT

South East Asian pharmaceutical market is rising quickly. In Asian country, the regulatory environment is parallel among all countries. But still requirements and procedure of registration is changing among countries of Asian region. Although ACTD is harmonized for all ten countries but still every country varies in some of the local requirements such as administrative, technical, clinical and non-clinical documents. Among this country Philippines systematically control the manufacture, import, export, storage, distribution and sale of drugs. Aim of the current study is to discuss developing challenges and requirements posed by compulsory licensing for drugs in diseases such as cancer. In this article we have observed documents requires for registration fitting to anti-cancer category in Philippines. Documents like batch manufacturing record, process validation records, stability study which include long term and enhanced stability studies as per zone specification of Philippines, packing requirements for anti-cancer drug and certificate for product authorization required for registration, which has enclosed all features from manufacturing to its packing and registration. This article will give the easy understanding on the drug registration necessities for anti-cancer drug in Philippines.

Keywords: ASEAN, ACTD, Philippines, Anti-Cancer, Registration.