Podcast
Questions and Answers
What percentage of total pharmaceutical exports of the Philippines did imports account for in 2021?
What percentage of total pharmaceutical exports of the Philippines did imports account for in 2021?
- 70-80% (correct)
- 50-60%
- 30-40%
- 90-100%
What was the export value of pharmaceuticals from the Philippines in 2021?
What was the export value of pharmaceuticals from the Philippines in 2021?
- EUR10.5 million
- EUR43.8 million (correct)
- EUR1.9 billion
- EUR1.16 billion
Which of these countries was NOT listed as one of the top suppliers of pharmaceuticals to the Philippines?
Which of these countries was NOT listed as one of the top suppliers of pharmaceuticals to the Philippines?
- USA
- Germany
- Japan (correct)
- Belgium
What significant event primarily influenced the increase in import value of pharmaceuticals in 2021?
What significant event primarily influenced the increase in import value of pharmaceuticals in 2021?
What was the CAGR for export value growth of pharmaceuticals from the Philippines over the last 5 years?
What was the CAGR for export value growth of pharmaceuticals from the Philippines over the last 5 years?
Which market accounted for the highest share of pharmaceutical exports from the Philippines in 2021?
Which market accounted for the highest share of pharmaceutical exports from the Philippines in 2021?
During which years did export value of wadding, gauze, bandages, and similar products grow significantly?
During which years did export value of wadding, gauze, bandages, and similar products grow significantly?
How much did the export value for wadding, gauze, and bandages reach in 2021?
How much did the export value for wadding, gauze, and bandages reach in 2021?
What is the first step in the application process for a license to operate (LTO)?
What is the first step in the application process for a license to operate (LTO)?
What triggers a notification to the applicant during the LTO evaluation step?
What triggers a notification to the applicant during the LTO evaluation step?
Under what condition may the pre-opening inspection for some establishments be waived?
Under what condition may the pre-opening inspection for some establishments be waived?
How long does the processing of LTO take for distributors, importers, and retailers?
How long does the processing of LTO take for distributors, importers, and retailers?
What is the role of the Center for Drug Regulation & Research (CDRR) under the FDA?
What is the role of the Center for Drug Regulation & Research (CDRR) under the FDA?
What happens after the approval and issuance of the LTP?
What happens after the approval and issuance of the LTP?
What is required before applying for a Certificate of Product Registration (CPR) in the Philippines?
What is required before applying for a Certificate of Product Registration (CPR) in the Philippines?
What is the total estimated time for the complete licensing process through e-LTO?
What is the total estimated time for the complete licensing process through e-LTO?
Which of the following entities is responsible for the regulation of health products in the Philippines?
Which of the following entities is responsible for the regulation of health products in the Philippines?
What does the ASEAN common technical dossier pertain to?
What does the ASEAN common technical dossier pertain to?
What does the FDA monitor to ensure compliance with quality standards?
What does the FDA monitor to ensure compliance with quality standards?
What is a common reason the licensing process for retail can extend up to 6 months?
What is a common reason the licensing process for retail can extend up to 6 months?
Which of the following activities requires entities to have a License to Operate (LTO)?
Which of the following activities requires entities to have a License to Operate (LTO)?
What is the function of the FDA's regional field offices?
What is the function of the FDA's regional field offices?
What must entities obtain for each pharmaceutical product they wish to market in the Philippines?
What must entities obtain for each pharmaceutical product they wish to market in the Philippines?
Which statement best describes the Total Household Final Consumption Expenditure?
Which statement best describes the Total Household Final Consumption Expenditure?
Which country is expected to see a significant increase in generic medicine consumption by 2025?
Which country is expected to see a significant increase in generic medicine consumption by 2025?
What trend has been observed in the Philippine population's attitude toward health and wellness post-COVID-19?
What trend has been observed in the Philippine population's attitude toward health and wellness post-COVID-19?
Which of the following diseases has a high incidence in the Philippines according to health statistics?
Which of the following diseases has a high incidence in the Philippines according to health statistics?
Which regions contribute the highest percentage of recorded diseases in the Philippines?
Which regions contribute the highest percentage of recorded diseases in the Philippines?
What is a significant concern raised by industry actors regarding the pharmaceutical sector in the Philippines?
What is a significant concern raised by industry actors regarding the pharmaceutical sector in the Philippines?
What is the common consumer trend in the Philippines regarding medication choices?
What is the common consumer trend in the Philippines regarding medication choices?
Which of the following countries is NOT mentioned as a notable importer of pharmaceuticals?
Which of the following countries is NOT mentioned as a notable importer of pharmaceuticals?
What significant change has occurred in the manufacturing landscape of the Philippine pharmaceutical industry?
What significant change has occurred in the manufacturing landscape of the Philippine pharmaceutical industry?
Which country conducted the most clinical trials in ASEAN in 2019?
Which country conducted the most clinical trials in ASEAN in 2019?
Which of the following companies is NOT listed as a multinational corporation in the Philippine pharmaceutical industry?
Which of the following companies is NOT listed as a multinational corporation in the Philippine pharmaceutical industry?
What is the primary focus of local pharmaceutical companies in the Philippines?
What is the primary focus of local pharmaceutical companies in the Philippines?
In what year did the Philippines rank 4th among ASEAN countries for clinical trials conducted?
In what year did the Philippines rank 4th among ASEAN countries for clinical trials conducted?
Which of the following is a characteristic of toll manufacturers in the Philippine pharmaceutical industry?
Which of the following is a characteristic of toll manufacturers in the Philippine pharmaceutical industry?
Among the following companies, which one is known for its toll manufacturing services in the Philippines?
Among the following companies, which one is known for its toll manufacturing services in the Philippines?
Which company is listed as a major player in the Philippines, known for manufacturing its own brands?
Which company is listed as a major player in the Philippines, known for manufacturing its own brands?
Which of the following correctly describes the status of multinational corporations in the Philippine pharmaceutical industry?
Which of the following correctly describes the status of multinational corporations in the Philippine pharmaceutical industry?
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Study Notes
Pharmaceuticals in the Philippines (2021 Overview)
- Import value constituted over 70-80% of total pharmaceutical exports, primarily due to Covid-19 vaccine importation.
- Import value of pharmaceuticals grew nearly sevenfold from the previous year, reaching EUR 1.9 billion.
- Export value for pharmaceuticals was recorded at EUR 43.8 million, indicating a disparity between imports and exports.
- Export value for medicaments (retail sale form) reached EUR 10.5 million in 2021, with significant growth from 2017 to 2021 at a CAGR of 41.3%.
Top Import and Export Markets
- Major suppliers of pharmaceuticals to the Philippines include the USA, China, Germany, India, and Belgium.
- Key export destinations for Philippine pharmaceuticals are Asian markets: Singapore (23%), Thailand (37%), Japan (15%), and India (12%).
Regulatory Environment
- The Food and Drug Administration (FDA) under the Department of Health (DOH) regulates health products including pharmaceuticals.
- FDA responsibilities include licensing, accreditation, market assessments, post-marketing surveillance, and quality monitoring.
- A License to Operate (LTO) and a Certificate of Product Registration (CPR) are required for manufacturers and importers of pharmaceuticals in the Philippines.
Licensing Process
- LTO applications require filing, evaluation, and inspection, which can take up to 6 months for retail level approval.
- The electronic licensing process (e-LTO) introduced in September 2016 streamlines the process to about 90 calendar days.
- Post-licensing inspections ensure ongoing compliance with standards.
Trends in Pharmaceutical Consumption
- There is a growing demand for generic medicines due to high medicine costs; the generic segment is projected to comprise 64% of the retail sector by 2025.
- A shift in consumer attitudes towards health and wellness, influenced by the Covid-19 pandemic, is driving changes in purchasing habits.
Common Health Issues and Regional Concentrations
- Acute respiratory infections, hypertension, and pneumonia are prevalent conditions driving medicine demand.
- The National Capital Region, Ilocos Region, and Eastern Visayas are the highest contributors to disease cases.
Market Dynamics
- The Philippine pharmaceutical market is becoming more concentrated with fewer local manufacturers.
- The regulatory environment allows foreign firms to operate without establishing local manufacturing plants.
- Manila is a preferred destination for clinical trials, ranked 4th in ASEAN based on clinical trial numbers.
Major Players in the Industry
- Multinational corporations dominate the market, including GlaxoSmithKline, Pfizer, and Sanofi-Aventis.
- Local manufacturers like United Laboratories and Pascual Laboratories have diverse roles, producing medicines for various distribution channels, including contract manufacturing.
- Toll manufacturers in the country provide specific production services for drug traders, enhancing the supply chain.
Summary
- The pharmaceutical sector in the Philippines is heavily reliant on imports, with a shifting focus towards generics and regulatory compliance driving market changes amid increasing health awareness among consumers.
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