Food and Drug Administration (FDA) Philippines in Transitional Status

From its former name Bureau of Food and Drugs (BFAD) to its new name Food and Drug Administration,(FDA). FDA Philippines is in transitional situation. Because of this transition business registration, processing, offices, manpower, budgeting, schedule of fees, regulation, policies and other scope of their power are constantly changing in accordance with the FDA Act of 2011.

This article focuses on the changes of registration and processing of application. Maybe a lot of business owners, personnel, and liaisons, especially those pharmacists' of companies, are confused of these changes the agency are imposing. Most of their policies and regulations are unstable and changing every time. Why is that so?

Here are few things why FDA Philippines is imposing such changes:

1. To efficiently bring service to the public.
2. To eliminate unscrupulous processing of applications with fixers, bribe and red tape.
3. To mandate full regulation and product surveillance in the the market.
4. To mandate full regulation of the laws.
5. To sustain high quality of products, and balanced employment and services.
6. To be competent enough for international regulations and standards.
7. To carry out public information and dissemination of rights of the end users.
8. To generate income to sustain the institution itself.
9. To give ease and facilitate business registration and applications.
10. To standardize application and processing rules.

Opinion:

But what I can see now is that the agency is in the middle of trial and error, searching for the best scheme to follow. Example is the future of online application. NCR and Region IV-A have already mandated to do so. However, as I read the terms of processing and procedures I felt the online processing would cost the public longer application time and redundancy. I attended a seminar conducted by FDA Region 1 and alike was also discussed. I had watched also the informative PAIR discussion youtube video in FDA site, also available here, and I found it very hard to accomplish. I have to say this because of the following reasons:

1. Step-by-step procedures have time limit and/or scheduled. When scheduled date is missed rescheduling will be given and if no show on the rescheduled date application will be denied and payment shall not refund.
2. Payments are either bank payment or cashier payment and also terms in No. 1 are applied.
3. You should know your computer more, because most of the application processes use computer and internet.
4. Documents and other requirements are to be scanned and saved to USB and submit to FDA.
5. It makes the application processes longer and tedious.
6. Although it is online application, why are you mandated to go to their office to submit original documents.
7. And if ever the online application is fully implemented, another problem will arise. When I attended seminar in the FDA Region 1 two months ago they disclosed that FDA regional offices will be removed, so that regional FDA offices and regional food and drug regulatory officers (FDRO) will be clustered. For example, clustering the Region 1, 2, 3 and CAR. And another thing any FDRO can inspection you any time, he or she may come from another region or unexpectedly an officer from FDA Alabang. They added FDA wants to achieve paperless and centralized application.
8. Another thing if the online application will be fully implemented and regional offices will be eradicated, pharmaceutical companies from Mindanao, Visayas and Northern Luzon need to travel by land or air just to submit the documents and requirements needed to finish the application. That will be expensive, time consuming, redundant, no assurance if your application will be approved.
9. There is no assurance if the online application will be successfully submitted or received by both applicant and receiver. You cannot remove the reality of err and fallibility.
10. Submission of insufficiency and lacking need to be scheduled before they entertain you.
11. You need to watch the PAIR youtube video to understand what I say.

If there are disadvantages of online processing there also advantages of it.

1. They say LTO will be sent to your respective email address. Moreover, LTO can be easily get is also can be easily revoked or suspended when the insufficiency and violations are found during inspection.
2. Tracking application can remove worries about the application status.
3. Can pay to any branch of Landbank.

Conclusion:

The role of FDA in the public is to give service and regulate pharmaceutical businesses. The public needs efficient, facilitated and consistent policies and procedures to make their errands and works more convenient. For me I want the old system of business application, because you do not need to schedule you application to be able to be entertained. The old system is a one day processing if ever there is no lacking or problem. Submission, interview and payment can be done in one errand and voila you are finished. What you need to do next is to wait for the inspection to be done and when everything is okay you will wait for you LTO to be delivered or released. Unlike this new system, you need to apply online, wait for your reference code, submit online, schedule payment, schedule submission of payment, scanned docs, saved in USB and submit again. And in the end you need to appear in their MAIN OFFICE in Alabang to submit everything. So why should I waste my time in all of that, provided, when in the end I will be appearing in their office still. So I keep saying the redundancy word because of that.

I am not against online application. My concern is that I hope the processing will be only one day processing and does not need to go around the bush. It should be direct and simplified. I hope FDA Philippines will be opted to give the public an option whether to apply online or apply physically. And I hope that the regional offices will not be disappeared instead to strengthen them and fortify them to continue servicing the pharmaceutical industries that located in the far flung areas that cannot be simply reached by the main office.