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Registering Pharmaceutical Products in the Philippines Edmund S. Yang, President & CEO, Cordelion Inc.

The first step before any commercialization starts for pharmaceutical products in the Philippines is to get the product registration approval and certificate from the Philippine Food & Drug Administration (PFDA). The Certificate of Product Registration (or CPR) is awarded to pharma traders and distributors with an initial validity period of two years. A common question though is raised as to how long does it take for a pharmaceutical product to get registered from the time of submission of the required documents to actual approval – a scenario also often observed in other countries.

There is no simple answer as the review and feedback given by the regulatory agency on the submitted registration papers will determine whether further documents are needed to substantiate and support information and claims of the product. However, from experience, the average registration time for pharmaceutical products takes between 1 - 2 years before approval is granted with the corresponding issuance of the CPR.

By understanding the process and the realities that go with registering pharmaceutical products in the Philippines, companies applying for the CPR can work out a more realistic marketing plan and timetable for launching their products. Let’s review the process as to how product registration is conducted in the Philippines and the preparation needed to have the product approved for commercialization.

Product registration starts by completing the product dossier. This documents are usually provided for by the product manufacturers where the product is sourced, produced or manufactured. Products are generally classified whether the product will be produced locally or imported as finished products.

Product Dossier Before an application is submitted for product registration with the PFDA the company planning to import, manufacture, pack, distribute, export and sell drugs on retail must have a valid License To Operate (LTO). Approval for LTO usually takes about one to two months, valid for one (1) year and renewed every two (2) years.

For pharmaceutical product registration with the Philippine FDA, the following information must be submitted and is usually complied and contained in the product dossier:

• Approved License To Operate with the company classified either as a trader, importer, distributor and/or manufacturer.

• Certificates of Agreement between the Filipino importer and/or distributor and the manufacturer if the product is sourced outside the country.

• Certificates of Analysis and Specifications for each raw material used in the manufacture of the drug. This can be provided by the foreign manufacturer.

• Information regarding dosage and product formulation.

• Product labelling materials. There is a required format for labels according to their classification. For example, a pharmaceutical product planned as prescription product must bear the generic name of the product contained in a box and larger than the brand below, if a brand name is included. The label must also bear the Rx icon to distinguish them as prescription products.

• Stability tests or studies. Stability test are provided accordingly based on the climactic conditions in the Philippines. For products manufactured locally, a retaining batch is kept at specific temperature for a period of time and evaluated to determine the product’s stability over time.

• Documents to show specifications in regard to the manufacturing process, including production procedures, equipment used for production, packaging procedures and in-process controls.

• Product samples. This includes English-language labels with the brand and generic names as already explained, name of the product license holder, product registration number, dosage, precautions, indications for use, date of expiration and batch number.

Product Classification Depending on the classification of the product to be registered are the corresponding requirements. The main product categories or classifications are:

1. Pharmaceuticals 2. Food Supplements or Nutraceuticals 3. Cosmetics 4. Medical Devices

Products are classified as ….

Pharmaceuticals

Products classified as pharmaceuticals are those with therapeutic or medicinal value or indications. Examples are antibiotics, anti-hypertensives, pain relievers, anti-diabetics, neoplastic or oncology (cancer) products, and other products bought with prescriptions from doctors.

The PFDA requires a BA / BE (bioavailability / bioequivalent) study for new applications. For products manufactured or sourced abroad, a BA/BE study may already be available and can be used for registering the product. However, generic formulations from a different manufacturing is required to submit the BA/BE test done on the product. Pharma companies applying can get BA/BE studies done locally through one of the few accredited providers. The cost varies but is between Php 1.3 – 2.0 million (US$ 2,800 to US$ 4,300) depending on the product and requirement. BA/BE studies are required for all products that are taken orally (e.g., tablets, capsules, suspension and syrups).



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Food Supplements

Food supplements are products that are considered as food derivatives. They could be extracts, refined or processed from plants considered as food derived from vegetables like bitter gourd (ampalaya), malunggay, or fruits like mangosteen, pineapple or root crops like turmeric, ginger, etc. Another common examples are the vitamins. Sometimes these products are referred to as nutraceuticals alluding to their nutritional features or ‘natural’ property being its main attribute in keeping people healthy or free from diseases or medical conditions.

Over the years, many local (and even imported products) have been registered under food supplement category. One compelling reason is that registration timeline for food supplements are much shorter and does not require the rigidity that pharmaceutical products go through in as far documentary requirements are concerned.

Products classified as food supplements are not required to submit a BA/BE study unlike pharmaceutical products.

The average registration time to approval is usually shorter for food supplements, that is, between 6-8 months from time of submission. Cosmetics

Cosmetics are products used for enhancing beauty. Some cosmetics may be considered as medicinal and are sometimes referred to as cosmeceuticals.

For cosmetic products the Notification is the equivalent of the CPR that is given to pharmaceutical products. The time to register for cosmetic products is usually shorter than that of pharmaceutical products. The time get approval could range from 14 days to a month with the corresponding Notification from the PFDA. Medical Devices

The WHO defines medical devices as “instrument, apparatus, imple-ment, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s)”.

Medical devices must also be registered with the PFDA.

Registered Products The marketing and distribution company or trader owns the primary registration certificate of the product. The company can apply for a ‘mother CPR’ status if it intends to extend its CPR to other companies who would like to market the same product with the same formulation. This is called the ‘baby CPR’.

The PFDA, through the recommendation of the local drug manufacturers and marketers, has provided this option to facilitate registration of similar products in the market. This will allow more competitors and for the local marketing companies, the same provides a means to add to their portfolio especially for products whose patent has expired. The company who wishes to market their product under a

‘baby CPR’ can use the same manufacturing dossier and product registration documents when they apply for the CPR provided they will have the same manufacturer produce the product for them.

This type of arrangement is referred to officially as the Commercial List of Identical Drug Products (or CLIDP).

Validity Period Certificate of Product Registration

Pharmaceutical traders and distributors are initially given 1-2 years validity period subject to renewal. CPRs for products can be applied covering a 5-year period with the corresponding payment for the whole five years.

Product Expiry Date

On the other hand, new products are given 2-years expiry date while awaiting final results of stability tests on the retaining batch manufactured. The same company can then apply for an extension of expiration date (validity period) if favorable stability tests were observed and reported with the sample retaining batch of the product. Usually, the validity period can be extended for another year or 3-years.

For some products that have been in the market for quite sometime, the validity periods can reach up to 4-years. Nevertheless, these are subject to supporting stability tests results on the retaining batch of products.

New Developments Registering pharmaceutical products in the Philippines have not changed for some time. Although some requirements were added to enhance assurance for quality standards and safety of the product. In the case of new manufacturers, especially those products manufactured and imported from other countries, an ocular inspection by the PFDA is required. This requires actual visits of PFDA regulatory personnel to visit the manufacturing facility of foreign source.

Sending the PFDA inspection representative to visit the manufacturer will be at the expense of the local importer, trader or distributor. Once inspection is made, the PFDA may submit for approval the issuance of the CPR and the importation (Import License) of the said product. However, approval is not guaranteed and will depend on the findings and recommendation of the PFDA inspector or inspecting team.

Summary The aim of the PFDA is to shorten the approval period from its current average. However, the challenge remains as more and more pharmaceutical companies are coming into the market who are earnest in marketing as many products as possible. This is on top of the already existing companies who are also opt to increasing their product lines and expanding their portfolio entering new markets to compete in.

Pharmaceutical companies couldn’t but agree as they will be the primary beneficiary if product registration approval timeline can be reduced.

The PFDA is also enhancing its regulatory function by complying with international standards in response to the plan to harmonize globally the requirements for drug registration. The direction will have its corresponding challenges as well as opening up opportunities that could benefit Philippine pharmaceutical companies.



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For more information about Cordelion, Inc. and its services contact:

CORDELION, INC. (LTO: CDRR-NCR-CRO-8)

Level 10-1, One Global Place Building, 25th Street and 5th Avenue, Bonifacio Global City, 1634 Taguig City, Philippines

Tel: +63.2.224.4328

e-mail: [email protected]

Mobile: 0917.935.1423

Website: www.cordelion.com