Product test reports
HO CHEE MENG
Crafting high-quality traditional Chinese medicine products through the combination of traditional craftsmanship and scientific methods
Malaysia's Pharmaceutical Regulatory Authority
Traditional Chinese medicine manufacturers need to meet all the quality requirements set by Malaysia's Pharmaceutical Regulatory Authority in order to ensure the health and safety of consumers. Therefore, these manufacturers must abide by all the stipulations of the "Drug Registration Act" issued by the Authority, and apply for drug registration approval. This law details all the information and requirements necessary for drug registration, including the ingredients, properties, manufacturing process, quality control, drug safety, clinical trials, and efficacy data. Chinese medicine manufacturers need to submit all the necessary documents, and prove the safety of the drug through clinical trials, to gain permission and produce qualified Chinese medicine products.
Traditional Chinese medicine manufacturers also need to comply with the GMP (Good Manufacturing Practices) standards issued by Malaysia's Pharmaceutical Regulatory Authority. These standards detail the best practices for drug manufacturing and quality control, ensuring the quality, safety, and efficacy of drugs. Traditional Chinese medicine manufacturers need to ensure that their production facilities meet GMP standards, and establish a comprehensive quality management system to monitor the quality and safety of products. Only by passing strict drug registration and quality review procedures can Chinese medicine manufacturers obtain production licenses, and provide the market with high-quality Chinese medicine products that comply with regulations and standards.
| PRODUCTS | REGISTRATION NUMBER |
|---|---|
| GINSENG NINGSAUN WAN | MAL19970355T |
| WU CHIN WAN | MAL19970357T |
| HUA TAN CHIN KHEN WAN | MAL19972263T |
| ZHUI FENG SOO HUP WAN | MAL19972264T |
| CHIN CHING WAN | MAL19984930T |
| PAU CHEE SAN | MAL19984932T |
| BUK FUNG PILLS | MAL19987103T |
| PO YIN TAN | MAL19987104T |
| CHIN FONG SAN | MAL19984931T |
| TIEN CHI TIEH TA WAN | MAL20040042T |
Traditional Chinese Medicine needs to be registered
All traditional Chinese medicines must be registered and reviewed by the National Pharmaceutical Regulatory Agency under the Ministry of Health, and must obtain approval. After approval, they will receive a registration number, typically prefixed with 'MAL' and suffixed with 'T'. All legally registered traditional Chinese medicines have two characteristics: a product registration number prefixed with 'MAL' and a laser anti-counterfeit label from the Ministry of Health on the packaging. The purpose of product registration is to ensure that all registered traditional Chinese medicines have undergone evaluations for safety and quality, ensuring the safety of the traditional Chinese medicine.
We can verify the legality of traditional Chinese medicines using the National Pharmaceutical Regulatory Agency's website ( Click here to enter the website - NPRA）
Heavy Metal and Microbial Testing
Every batch of traditional Chinese medicine must undergo testing to ensure that it meets the requirements for heavy metal and microbial limits. This is because traditional Chinese medicines are often extracted from natural plants, minerals, and animals, which may be affected by environmental pollution and microbial infection.
Heavy metals refer to certain metal elements that are ubiquitous in nature, such as lead, mercury, cadmium, and arsenic. During the production of Chinese medicine, these metals may contaminate the medicinal materials and pose a threat to human health. Therefore, traditional Chinese medicine manufacturers need to ensure that the heavy metal content of each batch of Chinese medicine does not exceed the limit requirements of the Malaysian Drug Regulatory Authority.
Microorganisms refer to tiny organisms that are ubiquitous in nature, such as bacteria, fungi, and viruses. These microorganisms may contaminate medicinal materials and reproduce during the production process, posing a threat to human health. Therefore, traditional Chinese medicine manufacturers need to ensure that the specific microbial content of each batch of Chinese medicine meets the limit requirements of the Malaysian Drug Regulatory Authority.
The Limit Requirements
The following limit requirement chart is only applicable to ZHUI FENG SOO HUP WAN，PO YIN TAN，CHIN CHING WAN，WU CHIN WAN，CHIN FONG SAN，BUK FUNG PILLS，GINSENG NINGSAUN WAN
| 重金属 Heavy Metal Test | The Limit Requirements / ×10^-6 |
|---|---|
| 铅 Lead | ≤10.0 ppm |
| 砷 Arsenic | ≤5.0 ppm |
| 汞 Mercury | ≤0.5 ppm |
| 镉 Cadmium | ≤0.3 ppm |
| 特定微生物测试 Microbiological Test | The Limit Requirements |
|---|---|
| 需氧微生物总量 Total Aerobic Microbial Count | 不超过 2 x 10^4 CFU/g Not more than 2 x 10^4 CFU/g |
| 酵母菌、霉菌总量 Total Yeast & Moulds Count | 不超过 2 x 10^2 CFU/g Not more than 2 x 10^2 CFU/g |
| 胆汁耐受革兰氏阴性菌 Bile- Tolerant Gram-Negative Bacteria | 不超过 1 x 10^2 CFU/g Not more than 1 x 10^2 CFU/g |
| 大肠埃希氏菌 Escherichia coli | 1g 中没有 Absence in 1g |
| 沙门氏菌 Salmonella | 10g 中没有 Absence in 10g |
| 金黄葡萄球菌 Staphylococcus auerus | 1g 中没有 Absence in 1g |
The following limit requirement chart is only applicable to PAU CHEE SAN，TIEN CHI TIEH TA WAN，HUA TAN CHIN KHEN WAN
| 重金属 Heavy Metal Test | The Limit Requirements / ×10^-6 |
|---|---|
| 铅 Lead | ≤10.0 ppm |
| 砷 Arsenic | ≤5.0 ppm |
| 汞 Mercury | ≤0.5 ppm |
| 镉 Cadmium | ≤0.3 ppm |
| 特定微生物测试 Microbiological Test | The Limit Requirements |
|---|---|
| 需氧微生物总量 Total Aerobic Microbial Count | 不超过 5 x 10^4 CFU/g Not more than 5 x 10^4 CFU/g |
| 酵母菌、霉菌总量 Total Yeast & Moulds Count | 不超过 5 x 10^2 CFU/g Not more than 5 x 10^2 CFU/g |
| 胆汁耐受革兰氏阴性菌 Bile- Tolerant Gram-Negative Bacteria | 不超过 1 x 10^2 CFU/g Not more than 1 x 10^2 CFU/g |
| 大肠埃希氏菌 Escherichia coli | 1g 中没有 Absence in 1g |
| 沙门氏菌 Salmonella | 25g 中没有 Absence in 25g |
