Food and Drug BlogFDA – New Guidelines for Drug Importers

July 7, 20140

The Department of Health followed WHO’s lead of adopting and implementing Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products and Annex 9 to GSP for Pharmaceuticals after releasing Administrative order number 2013-0027.

This is because of the continuous advancement in the Pharmaceutical field that also needs for continuous improvement in the safety and efficacy of new pharmaceutical products that are sold in the market and are being bought by the citizens.

The administrative order seeks to coordinate the transition period of the FDA and the registered drug establishments in the country from the previous guidelines to the new WHO GDP and GSP guide and supplement A.O. 56 s. 1989 (Revised Regulations for the Licensing of Drug Establishments and Outlets) and other related RA’s.

The adopted guides shall be made accessible at government websites including the FDA and drug establishments and retailers registered under the FDA will be inspected using the WHO GDP and GSP guides after its successful circulation in the country. After one year of transition period to comply with WHO’s Annex 5 and 9, a strict implementation of this new law will be applied.

As stated on the issued administrative order, inspection of drug establishments and retailers will be inspected using WHO guidelines. Standard Operating Procedures regarding all controls on activities involving distribution from the supplier down to the importer/wholesaler/retailer should be in complaint with WHO guidelines.

Although the new areas of biological and radiopharmaceuticals, etc., are the ones that are targeted by this Administrative order, another aim of these improvements are to ensure that high quality medicines are produced in line with the Pharmaceutical Inspectorate Cooperation Scheme (PIC/s).

The FDA adhered to the 1987 Philippine Constitution Sec. 12 Article 13, which states that “the state shall establish and maintain an effective food and drug regulatory system”, and pursuant to the provisions of Republic Act No. 9711, otherwise known as FDA Act of 2009 Section 3.

With this move of our FDA, customers and drug manufacturers alike will be more comfortable with one another for another great leap of adjustment for the benefit of all is made.

Supplementary information on the released FDA official advisory about the adoption and implementation of Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products and Annex 9 to GSP can be accessed at FDA website.

For companies who want to register their drugs and pharmaceuticals, our Regulatory Affairs Department can offer assistance in preparation of all the documents needed and elude rejection and incomplete documents and minimize processing time.

Ria David – Regulatory Affairs Consultant

Unit 616 Tower One Stock Exchange
Makati City, Philippines 1226
T:+63 (02) 566 5240

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