FDA approvals for micro enterprises made easier

FDA approvals for micro enterprises made easier
Memorandum of Understanding to fast track the process of getting permits from the Food and Drug Authority (FDA). From Left: FDA Director General Nela Charade Puno, DOH Undersecretary Rolando Enrique Domingo, DOH Secretary Francisco Duque III, and DTI Secretary Ramon Lopez

To address the clamor of the growing micro enterprises in the country that brought up their concern on the bureaucratic system of getting permits from the Food and Drug Authority (FDA), the Department of Trade and Industry (DTI) and the Department of Health (DOH) launched a six-month pilot program for micro enterprises in getting their FDA permits. Even as the program focuses on businesses producing low-risk food products with assets not more than Php 3 million, the FDA is embarking on an online portal to further simplify the FDA application compliance.

“This is a product of close and strong collaborations between the DTI and DOH. We employ a whole-of-government approach to achieve President Duterte’s goal of helping the little guys, the micro enterprises. These people chose to change the course of their lives through starting a business. Hence, we need to lessen their hurdles in growing their business and mainstreaming their products,” said DTI Secretary Ramon Lopez.

Sec. Lopez, DOH Secretary Francisco Duque III, DOH Undersecretary Rolando Enrique Domingo, and FDA Director General Nela Charade Puno signed a Memorandum of Understanding in 21 December to launch the pilot program.

Changes and implementation will take place on January 2019, wherein the FDA will post their representatives in all DTI Negosyo Centers in the National Capital Region to train micro enterprises and pre-assess their applications for Licenses to Operate (LTOs). Upon passing the pre-assessment, these applications will be forwarded to the FDA, who committed to release the LTOs in 15 days. Under the program, these micro businesses will also be exempted from getting Certificates of Product Registration (CPRs).

Low-risk products, as listed in the FDA Circular 2016-014 include:

  • Fats, oils, and fat emulsions
  • Processed fruits, vegetable and edible fungi, seaweed, and nuts and seeds
  • Confectionery
  • Cereal-based products
  • Processed meat and meat products, including poultry and game
  • Bakery wares and bakery related products
  • Sweeteners, including honey
  • Salt, spices, soups, sauces, salads, and protein products
  • Beverages
  • Ready-to-eat savories, like potato chips and chicharon.

Secretary Duque conveyed his appreciation to DTI in being a strategic partner of DOH and FDA, He also committed to balance ease of doing business with consumer health and safety.  “Ensuring the safety of products by micro enterprises points to DOH’s mandate to protect the consumers most of all. They are the reason we’re doing this,” said Sec. Duque.

After the pilot run, the agencies will evaluate the program’s effectiveness and prepare for a possible rollout in more regions throughout the Philippines.

Meanwhile, FDA Director General Puno said that the program aims to first gauge the response of entrepreneurs to this change. This is also part of FDA’s move to be a more agile organization. She assured that FDA will not be a barrier to trade while continuously upholding public health.

The FDA is also working on an online portal that allows users to fill out forms and pay online. The portal named IDOL, or Initiative ni Digong Operation Livelihood, will have training modules to walk applicants through the process of getting FDA permits and licenses.

Leave a Reply

Close Menu