Medical network - May 2, 28, at night, the CFDA website "on further strengthening the views of the health food supervision (draft)" (hereinafter referred to as "opinions"), put forward "gradually formed the record is the most, the approval is one of the registered new pattern" of important premise. 

 

In other words, most supplements don't have to be reapproved! 

 

▍ reform of examination and approval 

 

According to the opinion, the CFDA will make major changes in health food regulation including: 

 

We will steadily advance the filing of health food products. Formulate measures for the management of health food raw materials and health care function directory, the directory organization to carry out the raw materials from the argumentation and incorporated into the work, to take "public application, public argument, the result of the way, from vitamin mineral raw materials, a single raw material formula and homogenized formulas of three level progressive type gradually expanding the scope of the raw materials directory, pushing of the opening products for the record management, and gradually form the record is the approval is one of the most, registered a new pattern. Based on the health food raw materials catalogue, the national health food registration information system is based on the information system of the health food filing system. 

 

Make clear the basic position of healthy food. Health food is different from drugs and common food of a kind of special food, including the normal dietary nutrients supply of dietary supplements and claims to have the function of promoting human health food. There is no substitute for a normal diet, for the purpose of treating the disease, and no substitute for drugs. 

 

In principle, health food functions claim to be validated by human consumption. According to the scientific consensus degree and human consumption and scientific basis for the verification, claims that the function add descriptive terms restrictive terms and science to guide consumption. 

 

Health food should be clearly marked with special marks, and product names should not be named after the health function. 

 

Revising perfect health food advertising regulatory system, clear the certificate holder AD main body responsibility, clearly defined ads illegal behavior, increase the intensity of advertising supervision and punishment, relying on the credit system adopts a joint punishment. The instructions for health food labels and advertisements should be noted that "there is no substitute for medicine". Ordinary food may not claim the efficacy of the product. 

 

Health food for the record, it is to point to health food production enterprises in accordance with legal procedures, conditions and requirements, will show the product safety, the health care function and the quality control of materials submitted to the food and drug supervision and administration department for filing, open, for future reference. 

 

In recent years, the country's reform of health food regulation has accelerated significantly. 

 

In January, the drug safety administration issued "health food raw materials directory (a)" and "allow health food says the health care function of directory (a)", let the health food records the implementation basis; On February 7, national food drug safety administration formally issued a "health food for the record work detailed rules" (draft), the details of a total of 8 categories, 22 pages, made detailed instructions for the record for manufacturing enterprises. 

 

Scope of application of the rules involve the filing work, registration form and content of the record filing materials, domestic health care products for the record, imported health food registration requirements, for the record, for the record to cancel, change information, and many other aspects. 

 

The CFDA website on March 1, "health food registration and filing management method" (the state food and drug supervision and administration of administration makes no. 22), announced that shall enter into force as of July 1, 2016. 

 

After the revised version, was released on April 30, 2005, the health food registration management measure (trial) "(formerly the state food and drug administration makes no. 19). 

 

As of now, the food and drug administration data show that there are 15,528 batches of health food in the country, and 746 batches of imported health food products, according to public figures. 

 

According to Chinese medicine and health products import and export chamber of commerce, apart from cross-border electricity, the sea and purchasing, the scale of the imported health food now has about $1.2 billion. 

 

Zhang Zhongpeng deputy director of the Chinese medicine and health products import and export chamber of commerce, said the measures for the management, for imported health food is good, "although the imported health food only in the field can be added vitamins, minerals and other nutrients for the record, but at least a incision. Chinese health food market cake is very big still". 

 

Public information, at the beginning of 2016, Pfizer disclosed completing the acquisition can be pharmaceutical co., LTD., a wholly owned subsidiary of thousand Lin Jiankang industry co., LTD., and its 100% stake in qian Lin brand series of products; The company earlier expanded its health care market to buy a 74 per cent stake in McKinley. 

 

Attachment: 

 

The general office of the general administration of the general administration of the general administration of the general administration of the general administration of the general administration of the general administration of the general administration of the general administration of the general administration of the general administration of the state 

 

Health food industry is one of the important pillar industry of the food industry in China, China construction is to promote health, promote the development of "great health" industry, and promote the health services and pensions industry development important industry in our country, has been listed in "much starker choices-and graver consequences-in" national food safety plan. For the full implementation of the new revision of the "food safety law of the People's Republic of China (hereinafter referred to as the" food safety ") health food should be brought into the special food requirements of strict management, now on further strengthening health food supervision put forward the following opinions: 

 

One, guiding thought 

 

Fully implement the party's 18 large and 18 sixth plenary session of 3, 4, 5, spirit, in-depth study and implement general secretary xi series of important speech spirit, closely around as a whole to promote "five one" the overall layout and coordination to promote "comprehensive" four strategic layout, readjusting the innovation, the coordination, the green, open, sharing development idea, the implementation of the CPC central committee and the state council decision deployment, to carry out the "four most strict" requirements, to safeguard the people "on the tip of the tongue safe" as the core, adhere to the management, scientific management, in accordance with the "pipes", the combination of reform and reorganization, the work principle, construction of supervision system suitable for China's national conditions, promote the healthy and sustainable development of the industry. 

 

Second, the basic principle 

 

-- adhering to the law. In newly revised "food safety law and related laws and regulations as the basic follow, perfect the system of laws and regulations, perfecting supervision mechanism, clearly defined the registration for the record, production operators, technical evaluation agencies, the administrative department of each main body responsibility, implement the responsibility system, creating a favorable regulatory environment under the rule of law, safeguard fair competition in the market. 

 

-- stick to scientific management. Based on scientific theory, scientific data is the proof of scientific consensus, and the scientific and reasonable evaluation system of product evaluation system and technical evaluation system are constructed. Adhere to the science for development, science promotion regulation, guide consumption, continuously improve the technology level and international competitiveness of the industry as a whole, proceed with took to the track of innovative development of enterprises. 

 

-- stick to the "pipe suit". Adhere to the government regulation service, economic and social development through reform registration review approval system, straighten out the working mechanism, the filing management, fully give play to the role of market main body, stimulate the market dynamics, innovation consciousness, easing the burden on enterprises, help health China construction and development of "great health" industry. 

 

 

The previous page [1] [2]the next page