The Philippines will soon be adopting the ASEAN Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR) for pharmaceutical registration. There is currently no set date for this implementation, but the Department of Health has already released a draft administrative order. Pharmaceutical... Read More
On October 20, 2010, the Philippines’ Food and Drug Administration (FDA) under the Department of Health requested comments on a draft of the new administrative order for GMP of foreign drug manufacturers. The guidelines serve to establish a formal system of evaluation,... Read More
On July 19, 2010, the Philippines’ Department of Health signed Administration Ordinance No. 2010-0024. This ordinance requires a new permit (Department of Health Permit to Construct) as a part of the Free-standing Screening Drug Testing Laboratory (free-standing SDTL) Accreditation Process. This ordinance... Read More
Introduction With the United States emerging very slowly from a huge recession, some of Europe unable to pay its bills, and more restrictions coming from the US Food and Drug Administration (FDA), an area where medical device companies may want to focus... Read More
In March 2010, the Philippine Bureau of Food and Drugs (BFAD) announced that it would be issuing Automatic Renewals for Licenses to Operate (LTO) that are set to expire by the end of this year. These LTOs are those belonging to registered... Read More
The Philippine Department of Health has found that more than 100 drugstores and hospital pharmacies have not been complying with the price reduction programs that were established in August 2009. The Government Mediated Access Price (GMAP) and Maximum Drug Retail Price (MDRP)... Read More
The Philippine government is pushing for a second round of drug price cuts and for drug companies to voluntarily halve their prices. Pfizer, GlaxoSmithKline, and Novartis are just a few of the companies that may be targeted to lower prices of blockbuster... Read More
Asia is emerging from the global recession faster than other regions in the world. This article goes through some of the major regulatory updates in various Asian countries. Read More
The Filipino FDA held a public consultation on December 3, 2009 for its revised fee schedule. The increased fees are primarily to facilitate the recently approved regulations: the Food and Drugs Administration Act of 2009 and the Universally Accessible Cheaper and Quality... Read More
Under Republic Act 9711 or the Food and Drugs Administration Act of 2009, the new FDA (former BFAD) will have expanded authority and increased regulatory capacity in the Philippines. The new law will help make it easier for the government to make... Read More