| Pacific
Bridge Medical - The Philippines
Medical Publications |
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| Philippines: Product Registration for Pharmaceuticals
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| Published
by
Pacific
Bridge Medical |
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| By Ames Gross |
March 2000
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I.
Introduction to the Philippines
The Philippines
was hit hard by the Asian crisis. In 1998, the Filipino economy deteriorated
-- growth fell to a negative 0.5% from 5.0% in 1997. The Philippines government
has announced that its 1999 economic growth was 3.1%, above the IMF's estimate
of 2.5%. The government has promised to continue its economic reforms by improving
infrastructure, overhauling the tax system and increasing deregulation and the
privatization of the economy.
II. Pharmaceutical Market
The Filipino
pharmaceutical market in 1999 was estimated to be about 36.83 billion pesos
(about delete extra space $900 million). After Japan, Korea and Taiwan, the
Filipino pharmaceutical market is the fourth largest in Asia. The market grew
about 5.0% in 1999. Pharmaceutical products (both ethical and OTC) are primarily
distributed to customers via pharmacies (78%), hospitals (13%) and other channels
(9%). Mercury Drug Stores is the largest pharmaceutical chain in the Philippines
with about half of the overall pharmacy business. Major areas where therapeutic
products are used include anti-infective, respiratory, cardiovascular and the
central nervous system. Leading ethical products in the market include Ventolin
(Glaxo), Augmentin (Smith Kline), Ponstan (Warner Lambert), Plendl (Astra) and
Propan Iron (Rorer). While the Philippines is a large geographic area (about
the size as Italy) made up of many islands (20 islands account for 92% of the
landmass), the Metro Manila area accounts for about 50% of the pharmaceutical
market, the Luzon area about 25% and the remainder split between the Visayas
and Mindanao regions.
III. Pharmaceutical Healthcare Association of the Philippines (PHAP)
The PHAP
is an association composed of local and multinational pharmaceutical manufacturers,
traders, distributors and retailers. Affiliated with PHAP are six professional
organizations within the healthcare industry such as the Marketing Executives
in the Pharmaceutical Industry (MEPI), Pharmaceutical Executives of the Philippines
(PEP), Philippine Pharmaceutical Manufacturers Association (PPMA), Philippine
Association of Pharmacists in the Pharmaceutical Industry (PAPPI), Association
of Pharmaceutical Trainers (APT) and the Philippine College of Pharmaceutical
Medicine which is affiliated as a society of the Philippine Medical Association.
Mr. Leo P. Wassmer, Jr. is the Executive Vice President and Chief Executive
Officer of PHAP, a position he assumed after his retirement as General Manager
of Eli-Lilly ( Philippines), Inc. in 1990. PHAP can be contacted at the following
address:
Unit 502, One
Corporate Plaza, 845 Pasay Road, Makati City, Philippines Tel. # 815-03-25, Fax
# 819-27-02, E-Mail; phap7346@info.com.ph
IV. Product Registration
While rules
and regulations with respect to most things in the Philippines are quite "fluid",
the pharmaceutical regulatory environment is no different. The checklists below
should be helpful in navigating the process.
CHECKLIST
OF REQUIREMENTS INITIAL AND CONDITIONAL REGISTRATION
|
REQUIREMENT |
#
of copies |
1 |
Letter
of application |
2 |
2 |
Copy
of valid certificate of brand name clearance. |
1 |
3 |
Copy
of valid agreement between manufacturer and trader/distributor/importer/exporter
|
1 |
4 |
Unit
dose and batch formulation. |
2 |
5 |
Technical
specifications of all raw materials |
2 |
6 |
Certificate
of analysis of active raw material(s) |
2 |
7 |
Certificate
of analysis of finished product. |
2 |
8 |
Technical
specifications of finished product. |
2 |
9 |
Full
description of the methods used, the facilities and controls in the manufacture,
processing and packaging of the product. |
2 |
10 |
Details
of the essay and other test procedures for product including data analysis.
|
2 |
11 |
Detailed
report of stability studies to justify claimed shelf life. |
2 |
12 |
Sufficient
samples in market or commercial presentation for laboratory analysis (as
per M.C.20 s. 1994) and representative sample for PSD. |
2 |
13 |
Unattached
generic labeling materials; label, box, insert, blister/strip foil. |
2 |
14 |
For
imported drug product: a) Certificate of free sale from country of origin.
|
1 |
|
b)
Government certificate attesting to the status of the manufacturer as to
competency, reliability of personnel and facilities. |
1 |
|
a
& b) Authenticated by territorial Philippine consulate. |
|
15 |
For
drug product in plastic container |
|
15.1 |
Studies
done on the plastic to substantiate claim that product is safe to use:
a)
Components of the plastic used. b) Chemical tests. c) Physical tests d)
Biological tests (cell toxicity, tissue implantation, etc.d) for parental
and ophthalmic preparations. . |
2 |
15.2 |
Methodology
on how different tests were conducted and include limits (results) of each
test. |
2 |
15.3 |
Empty
plastic containers and closures. |
2 |
16 |
For
New Drug Application (if applicable): |
|
|
a)
Pre-clinical studies. |
1 |
|
b)
Clinical studies (phases I, II and III). |
1 |
|
c)
Protocol for monitored release. |
1 |
17 |
Certificate
of approval of PMS (if applicable). |
2 |
18 |
Bioavailability/bioequivalence
studies (for products under List B, as per B.C. #01 s. 1997). |
|
19 |
Requirements
for sterile products (as per B.C.#?). |
|
CHECKLIST
OF REQUIREMENTS FOR REGISTRATION OF FOOD PRODUCTS
- Letter
of application from manufacturer/exporter/importer.
- Valid
license to Operate. (LTO)
- Certificate
of brand name clearance from BFAD.
- Product
information
- List
of ingredients in decreasing order of proportion
- Amount
and technical specification of ingredients / additives used
- Certificate
from flavor supplier that the flavor components are recognized as safe and
suitable for human consumption either by the US Flavor Extract Manufacturer's
association, US Food and Drug Administration, International Organization
of Flavor Industry or other reputable agencies
- Physical
description and specifications of the finished product
- Samples
of the product in its commercial presentation.
- Labels
and labeling materials to be used for the product.
- Certificate
of analysis. (Include analytical methods used)
- Method
of manufacture, packaging (Food Grade Certification) and quality control.
- Stability
data in support of declared Expiry Date.
- Certificate
of agreement between the foreign manufacturer/distributor and the importer/local
distributor.
- Government
certificate of clearance and free sale of the product from the responsible
Government Authority in the country of origin and duly authenticated by the
Philippine Consulate abroad.
- Evidence
of registration for payment. (Charge slip/Official Receipt)
CHECKLIST OF REQUIREMENTS FOR REGISTRATION OF IN VITRO DIAGNOSTIC PRODUCTS
- Letter
of application from the manufacturer/trader/distributor. - one copy
- *Government
Certificate of clearance and free sale / registration approval of the product
from country of origin and duly authenticated by territorial Philippine Consulate.
- one copy
- *Government
Certificate attesting to the status of manufacturer, competency, and reliability
of the personnel and facilities, and duly authenticated by territorial Philippine
Consulate. - one copy
- *Certificate
of agreement between the manufacturer and distributor/importer regarding the
product involved. - one copy
- *Certificate
of brand name clearance. - one copy
- *Copy
of latest Certificate of Product Registration. - one copy
- List
of all raw materials used as components of the reagent/test kit. -
two copies
- Technical
specifications/physical description of the finished product. - two
copies
- Test
procedure and expected performance specifications. - two copies
- Flow
chart of the manufacturing procedure. - two copies
- Stability
studies of the product to justify claimed shelf life. - two copies
- Unattached
labeling materials (see attached guidelines on labeling of In Vitro Diagnostic
Products). - two copies
- Sufficient
samples (one sample/kit in market or commercial presentation for laboratory
analysis.
- Evidence
of registration fee payment. (* Initial Registration only **Renewal
Registration only)
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