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?
What was the export value of pharmaceuticals from the Philippines in 2021?
What was the export value of pharmaceuticals from the Philippines in 2021?
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?
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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)?
Signup and view all the answers
What triggers a notification to the applicant during the LTO evaluation step?
What triggers a notification to the applicant during the LTO evaluation step?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
What happens after the approval and issuance of the LTP?
What happens after the approval and issuance of the LTP?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
What does the ASEAN common technical dossier pertain to?
What does the ASEAN common technical dossier pertain to?
Signup and view all the answers
What does the FDA monitor to ensure compliance with quality standards?
What does the FDA monitor to ensure compliance with quality standards?
Signup and view all the answers
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?
Signup and view all the answers
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)?
Signup and view all the answers
What is the function of the FDA's regional field offices?
What is the function of the FDA's regional field offices?
Signup and view all the answers
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?
Signup and view all the answers
Which statement best describes the Total Household Final Consumption Expenditure?
Which statement best describes the Total Household Final Consumption Expenditure?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
Which regions contribute the highest percentage of recorded diseases in the Philippines?
Which regions contribute the highest percentage of recorded diseases in the Philippines?
Signup and view all the answers
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?
Signup and view all the answers
What is the common consumer trend in the Philippines regarding medication choices?
What is the common consumer trend in the Philippines regarding medication choices?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
Which country conducted the most clinical trials in ASEAN in 2019?
Which country conducted the most clinical trials in ASEAN in 2019?
Signup and view all the answers
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?
Signup and view all the answers
What is the primary focus of local pharmaceutical companies in the Philippines?
What is the primary focus of local pharmaceutical companies in the Philippines?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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?
Signup and view all the answers
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.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
Test your knowledge on the import and export dynamics of pharmaceuticals in the Philippines in 2021. Explore statistics regarding the significant growth in import values, particularly relating to Covid-19 vaccines and their impact on the market.
