The FDA is aware that a number of businesses or individuals provide services linked to FDA rules, such as helping with product approvals or offering guidance on regulatory compliance. It is important to remember that the FDA has not approved or recognized these services. The organization wants to warn the owners of companies that manufacture health products that the FDA does not accredit, certify, or recommend any consultant or consultant firms. To ensure that regulatory processes are business-friendly, the agency regularly analyzes its regulations and publishes updated guidance.
FDA has released Department of Health Administrative Order (DOH AO) No. 2020-0017, titled “Revised Guidelines on the Unified Licensing Requirements and Procedures of the FDA Repealing AO NO. 2016-0003”.This AO is in accordance with Republic Act No. 11032, also known as the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018,” which required all government offices to adopt streamlined requirements and procedures to cut down on red tape and speed up business and nonbusiness transactions in the government. The FDA has thus taken the following actions to reduce the regulatory burden and increase customer service:
- To speed up the processing of applications, the procedure was streamlined, and the license criteria were made simpler.
- Qualified Person in Industry Regulatory Affairs (QPIRA) credentials were no longer necessary to do business with the FDA or to authorize LTOs and other authorizations.
- The FDA eServices Portal was launched, and its Citizen’s Charter was reviewed and revised.
- Established the Food and Drug Action Center to address concerns and questions from stakeholders.FDA Academy often hosts webinars, and the DOH e-Learning Platform offers pre-recorded licensing webinars.
- The distribution of information, education, and communication (IEC) resources, including FAQs, video tutorials, pamphlets and booklets, infographics, and social media cards.
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Source: FDA Philippines
