Medicines (Rx)
Highlights
- Only Safe Sources
- We use Astragalus membranaceus (Fisch.) Bunge var. membranaceus, which complies with Good Agricultural Practices (GAP) and the WHO Pharmacopoeia. The herbal materials have passed strict pesticide residue testing and heavy metals inspection.
- Follow International Standards
- Taiwan's first PIC/S GMP sterile botanical drug manufacturing facility received a National Innovation Award in 2017 for its continual advancement of quality and safety measures.
- Strict Safety Monitoring
- We strictly adhere to all relevant laws and regulations, such as drug safety monitoring and Regulations for Reporting Severe Adverse Reactions to Medicaments to protect patients' safety and health.
In line with the United Nations’ Sustainable Development Goals (SDGs)
Safety Controls for Raw Medicinal Plant Materials
PhytoHealth carefully follows WHO Pharmacopeia designations and selection compliance when choosing the raw medicinal plant materials from the species Astragalus membranaceus. Using patented astragalus extraction methods, we purify effective polysaccharides for use in the manufacturing process for PhytoHealth PG2® Injection 500mg and AmazPower®.
- Refined astragalus polysaccharide (rAPS) is utilized as the main ingredient of PhytoHealth’s pharmaceutical-grade supplement AmazPower®, which is indicated for cancer patients who experience fatigue and weakness after chemotherapy and radiation therapy.
- Medicinal grade Astragalus Membranaceus is utilized to create PhytoHealth’s patented astragalus extract, which is central to the development of nutritional supplements such as Qi+ Liquid Herbal Energy® and EnerCharge® capsule.
In compliance with PIC/S GMP and GDP International Regulations
PhytoHealth constructed Taiwan's first Botanical Active Pharmaceutical Ingredients (API) manufacturing factory in accordance with the international Good Manufacturing Practice (GMP) for pharmaceuticals. In September 2016, the plant successfully obtained PIC/S GMP certification from the Taiwan Food and Drug Administration (TFDA), as well as Good Distribution Practice (GDP) approval.
The first PIC/S GMP sterile botanical drug manufacturing facility in Taiwan
Constructed Taiwan’s first sterile botanical drug manufacturing facility in accordance with PIC/S GMP regulations to strictly control and monitor the manufacturing process.
The innovative manufacturing process was recognized by the National Innovation Award
Phytohealth’s Botanical Active Pharmaceutical Ingredients (API) manufacturing factory was awarded the 14th National Innovation Award of Biotechnology Pharmaceuticals and New Medical Technology Group in 2017.
Drug Safety Monitoring
PhytoHealth has established standard operating procedures to collect adverse drug experience reports from healthcare professionals, sales personnel, and agents in the market, as well as domestic and foreign literature reports. We comply with relevant For Phytohealth 29 regulations and submit necessary reporting for Severe Adverse Drug Reactions (SADR).
For collected SADR reports, we promptly file cases and collaborate with relevant units such as clinical, research and development, sales, and quality assurance for evaluation and handling. We cooperate with the health regulatory authorities to improve the regulations and mechanisms for drug safety monitoring and implement necessary risk management measures.
Drug Traceability and Recall
Our company complies with the Regulations for the Management of Drug Safety Surveillance and promptly reports to the central health regulatory authorities within three days when any of the following situations occur with our drugs, starting from the date of our awareness:
- Discovery of serious adverse drug reactions that are unexpected or exceed expected frequencies.
- It becomes necessary to evaluate, add, or modify contraindications or usage restrictions.
- If the drug is suspended or withdrawn from use due to adverse reactions in the top ten most medically advanced countries.
- In other countries outside the above, if suspension or withdrawal of the drug is deemed necessary due to adverse reactions, it should be reported after evaluation.
After notifying the central competent authority, the following risk control measures will be implemented:
- Warnings issuing or other similar methods
- Revision of the Package Inserts
- Submit drug safety report
- Suspension of use and sales
- Product recall