U.S. health care products cause Zhejiang cGMP pharmaceutical companies concerned about the new regulations
U.S. Health Products Zhejiang New regulated cGMP pharmaceutical companies caused concern
Recently, the United States Food Drug Administration Management Authority (FDA) issued a "U.S. health industry to implement the provisions of cGMP," (the "Provisions"), on Health food Raw materials testing, sources will be more rigorous management. "Regulations" has aroused the concern of the enterprises of Zhejiang. Because Zhejiang Annual exports to the U.S. health care Food materials Number is not small, especially Vitamin Class raw materials exports is accounted for 90% of the country.
In accordance with the "rule" requires the United States over the next three years, all production and sales of vitamin / mineral Preparation , Plant preparations and a variety of dietary supplement companies to enforce cGMP (Dynamic Pharmaceutical Manufacturing Practice) transformation. No later than 5 years, to be completed on the health products business of cGMP transformation. In the future, all exports to the U.S. health food ingredients, must be the local authority's inspection reports, and this requirement is not the past. According to industry sources said, the domestic raw material suppliers of health food companies generally do not direct contact with local enterprises with the United States, but through intermediaries. Therefore, this stage of the export criteria in the blank, the supplier is to provide materials in accordance with enterprise standards, these standards are not FDA standards. The "rule" will be the Chinese health food companies have a tremendous impact on commodity exports.
Generally considered the province's industry, "require" the implementation of the health food raw materials export enterprises in Zhejiang Province have little effect. Zhejiang Food Health Association, said the Secretary-General Zhang Yan, Zhejiang, health food raw material exports to the United States are mostly concentrated in the Plant Extract And vitamins, mainly by the Hsin Chong Pharmacy Plant, Zhejiang NHU Co., Ltd. 2 production. The two companies were in fact the U.S. FDA in accordance with the requirements of production, raw material quality and very reliable. Zhejiang NHU Co., Ltd. A staff member also said that this "rule" has little effect on the company.
Previously, due to the health of domestic exports of food materials testing standards vary: some are qualified on their own inspection of enterprises, some state or local CDC to detect, leading to inconsistent testing standards, exports to the United States vulnerable to interception . "Require" the implementation, the United States to improve the standard of local businesses will have promoted the improvement of material standards, test items will increase, U.S. companies will also raw material suppliers to obtain more information on materials, which will increase the cost of export enterprises and difficult.
Zhang Yan believes that the U.S. implementation of the "rule" in the specification by the U.S. health food products imported to China is beneficial. Because of health food products enter the Chinese market abroad There are several channels: one is the application in accordance with the relevant provisions of national import health food batch, the channel quality health food products from abroad came to be reliable; the other is used to import batches of ordinary food health food (which are many), because people lack the expertise in this regard, it is difficult to judge their own experience with food quality is good or bad health. If the source can be regulated, then to improve the quality of the imported health food is helpful.
Recently, the United States Food Drug Administration Management Authority (FDA) issued a "U.S. health industry to implement the provisions of cGMP," (the "Provisions"), on Health food Raw materials testing, sources will be more rigorous management. "Regulations" has aroused the concern of the enterprises of Zhejiang. Because Zhejiang Annual exports to the U.S. health care Food materials Number is not small, especially Vitamin Class raw materials exports is accounted for 90% of the country.
In accordance with the "rule" requires the United States over the next three years, all production and sales of vitamin / mineral Preparation , Plant preparations and a variety of dietary supplement companies to enforce cGMP (Dynamic Pharmaceutical Manufacturing Practice) transformation. No later than 5 years, to be completed on the health products business of cGMP transformation. In the future, all exports to the U.S. health food ingredients, must be the local authority's inspection reports, and this requirement is not the past. According to industry sources said, the domestic raw material suppliers of health food companies generally do not direct contact with local enterprises with the United States, but through intermediaries. Therefore, this stage of the export criteria in the blank, the supplier is to provide materials in accordance with enterprise standards, these standards are not FDA standards. The "rule" will be the Chinese health food companies have a tremendous impact on commodity exports.
Generally considered the province's industry, "require" the implementation of the health food raw materials export enterprises in Zhejiang Province have little effect. Zhejiang Food Health Association, said the Secretary-General Zhang Yan, Zhejiang, health food raw material exports to the United States are mostly concentrated in the Plant Extract And vitamins, mainly by the Hsin Chong Pharmacy Plant, Zhejiang NHU Co., Ltd. 2 production. The two companies were in fact the U.S. FDA in accordance with the requirements of production, raw material quality and very reliable. Zhejiang NHU Co., Ltd. A staff member also said that this "rule" has little effect on the company.
Previously, due to the health of domestic exports of food materials testing standards vary: some are qualified on their own inspection of enterprises, some state or local CDC to detect, leading to inconsistent testing standards, exports to the United States vulnerable to interception . "Require" the implementation, the United States to improve the standard of local businesses will have promoted the improvement of material standards, test items will increase, U.S. companies will also raw material suppliers to obtain more information on materials, which will increase the cost of export enterprises and difficult.
Zhang Yan believes that the U.S. implementation of the "rule" in the specification by the U.S. health food products imported to China is beneficial. Because of health food products enter the Chinese market abroad There are several channels: one is the application in accordance with the relevant provisions of national import health food batch, the channel quality health food products from abroad came to be reliable; the other is used to import batches of ordinary food health food (which are many), because people lack the expertise in this regard, it is difficult to judge their own experience with food quality is good or bad health. If the source can be regulated, then to improve the quality of the imported health food is helpful.
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