How To Register A Business in The Philippines
How To Register A Business in The Philippines
How To Register A Business in The Philippines
Location Map
Barangay Clearance
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SEC Registration Documents
Occupancy Permit (Building/Unit)
Business Permit Application Form
Medical devices regulations in the Philippines are overseen by the Center of Device Regulation, Radiation
Health, and Research (CDRRHR) of the Food and Drug Administration, Department of Health. Republic Act
No. 9711 was enacted into law in August 2009 creating the Food and Drug Administration (FDA) in the
Department of Health (DOH), strengthening the regulatory authority over food, drug, cosmetics, medical
devices and other health devices.
IMPORTER:
WHOLESALER:
EXPORTER:
Devices not required to register may be sold after obtaining a Certificate of Exemption from the Department of
Health.
The validity of Certificate of Product Registration has been extended from 1 year to 5 years. Thus, new
application and renewal of application will have a certificate with validity of 5 years.
Philippines Pharmaceutical Registration: An
Overview
February 8, 2002 Leave a comment
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Foreign pharmaceutical companies control at least 75% of the local drug market in the Philippines.
Foreign firms’ market share is divided between several countries, with U.S. producers accounting for
about 10% of the market, and Switzerland, Germany, Australia, France, and the U.K. contributing
similar amounts. According to the U. S. Department of Commerce, U.S. exports to the Philippines
grew by 21.6% in 2000 to $8.79 billion and increased another 3.4% in the first quarter of 2001 (final
2001 figures are not yet available).
In order to market a pharmaceutical product in the Philippines, the product must first be registered to
the Philippine Bureau of Food and Drugs. The pharmaceutical registration process is relatively
straightforward (though as is often in the case in developing countries, having the right connections is
also just as important). An application for registration should include:
Additional regulations apply for imported products, products in plastic containers, and for new drugs.
This information is available from the Philippine Department of Health.
he Philippines is the 11th most attractive pharmaceutical market in the Asia-Pacific region and the
third-largest pharmaceutical market in ASEAN, after Indonesia and Thailand. The country’s
pharmaceutical industry is projected to grow by 4.5 per cent annually over the next five years
reaching P164 billion in 2018 from P146 billion in 2014 representing the value output or production of
industry, including research based pharmaceutical and generic companies, according to IMS
Consulting for the Pharmaceutical Healthcare Association of the Philippines (PHAP). The Filipino
pharmaceuticals is one of the fastest growing industries in the country and has grown year to year. Of
the world’s Top 20 pharmaceutical companies, over 14 have manufacturing facilities in the
Philippines. Business registration in the pharmaceutical industry in the Philippines is a growing and
expanding financial opportunity too. The pharmaceutical manufacturing sector ranks is listed in the
top 22 per cent of the 240 sectors in the Philippines.
“The Philippines is growing in so many ways; with one of the youngest populations in Asia, rapidly
increasing income and the ‘middle class’, foreign investment and business investment in outsourcing
and technology operations, and a large amount of overseas Filipino workers paying contributing large
amounts to GDP from across the globe. The shift has been made from infectious disease to
noncommunicable disease; with diet, alcohol and low exercise causing heart disease and other
conditions to grow rapidly. Healthcare products and medicines are in demand in the Philippines, but
the cost and availability in an out-of-pocket market means many products are out of geographical and
financial reach for many”, says Dr Edward Booty, CEO, Allied World Healthcare, the Philippines.
The Philippines has a higher utilization rate of lower-cost generics than other Asia-Pacific countries
with comparable GDPs. Generic medicine prescriptions by physicians has also increased by 7
percentage points since 2011 (from 66 per cent in June 2011 to 73 per cent in June 2014) enhancing
patient access to medicines.
The government’s bulk procurement of pharmaceutical products has also helped bring down prices of
medicines to Filipino patients. Changing manufacturing scenario Foreign drug companies account for
over 75 per cent of the pharmaceutical market. Some of the biggest foreign drug companies in the
Philippines are Sanofi, Pfizer and GlaxoSmithKline. It is also seen that there has been a huge growth
in generic drugs made by domestic and foreign pharmaceutical companies in the Philippines. The
fastest growing companies include Novartis’ generic arm Sandoz, Taiwan’s Orient Europharma
(OEP) and Getz Pharma of Pakistan. In total, there are more than 500 drug traders, 700 drug
importers, and 5,000 drug distributors in the Philippines. Over the years, the MNCs which had
manufacturing plants in the country closed down their facilities, and began to import from corporate
production centres abroad, or turn to local contract manufacturers. At the moment, only few
pharmaceutical multinationals have manufacturing facilities in the Philippines. However, the ones with
manufacturing plants find it cost-efficient to produce in the country. GlaxoSmithKline is one example
which has sustained its manufacturing in the Philippines.
“The importation of medicines (and other goods) has been traditionally challenging in the Philippines,
but a number of reforms are underway to streamline and improve this process. Manufacturing in-
country is a request many countries make to improve the number of high quality, local jobs – but a
pharma manufacturer cannot fully decentralize their operations as that would remove economies of
scale, and thus strategic choices will have to be made for global pharma as to whether the market
size, improved government relations, and potential reduction of logistics and taxation costs would
make economic sense overall”, comments Dr Booty on the changing Filipino scenario.
While many multinationals abandoned the Philippines, the local manufacturing industry became
livelier. The number of laboratories declined over the years, as many were not able to cope with
technological advancement and increasingly stringent requirements, but the ones that survived are
Good Manufacturing Practices (GMP) compliant and at par with the latest technologies.
In the same haste, pharmaceutical companies in the Philippines also undertake various activities in
the course of their business operations, which require the use of IPR. As part of their worldwide R&D,
originator companies are conducting clinical trials in the Philippines in an increasing number, such
that the Philippines is now ranked third in South East Asia, next to Thailand and Singapore in terms of
the number of pharmaceutical industry sponsored clinical trials, according to KPMG Report.
Government Initiatives
The Philippines government has doubled its efforts in improving the pharmaceutical market. This
increased intervention under the universal health care initiative and a growing acceptance of generic
drugs has caused a shake-up in the sector. Adding up to the complexity, optimistic growth forecasts
indicate a huge potential for the private sector.
Talking about the various initiatives taken by the Philippines government in the pharmaceutical
sector, Dr Booty says, “The Philippines government grew their ‘Health for All’ programme over the
past few years, with various programmes to improve digital services, deploy medical workers to rural
areas, create integrated ‘Service Delivery Networks’ and combat a number of other health challenges.
The pharma sector has seen a number of innovations, ranging from ePharmacy ordering, to local
health data innovations, to cross-pharma access programs in lower-income communities. Novartis
and Allied World Healthcare are pioneering community healthcare access models and financing
schemes, helping connect communities to essential healthcare support.”
● BnB Project: The Philippine government established Botika ng Barangay with the aim of increasing
the accessibility to health care products to people in rural areas where prices are 50 – 70 per cent
cheaper compared to leading brands. Botika ng Barangay refers to a drug outlet managed by a
legitimate community organization (CO or nongovernment organization (NGO) and/or the Local
Government unit (LGU), with a trained operator and a supervising pharmacist. This provides primary,
non-prescription generic drugs listed in the Philippine National Drug Formulary (PNDF) and selected
prescription drugs are sold/made available.
● Republic Act A 9502: Cheaper Medicine Act- The Philippine Government in 2007 created RA 9502
with the intention to achieve better health outcomes for Filipinos by assuring that quality medicines
are accessible and affordable to as many Filipinos especially the poor. The law and its implementing
Rules and Regulation intend to make medicines more accessible and affordable to Filipinos by
enforcing provision that improve market competition, availability, contain costs, improve health care
provider and consumers behaviour, and when instances so require, even regulate prices.
.
© 2020 R.G. Manabat & Co., a Philippine partnership and a member firm of the KPMG network of
independent member firms affiliated with KPMG International Cooperative, a Swiss entity. All rights
reserved.
KPMG International Cooperative (“KPMG International”) is a Swiss entity. Member firms of the
KPMG network of independent firms are affiliated with KPMG International. KPMG International
provides no client services. No member firm has any authority to obligate or bind KPMG International
or any other member firm vis-à-vis third parties, nor does KPMG International have any such authority
to obligate or bind any member firm.