pharmaceutical excipients will be new rules < p> 2017 -
16 13:24:42 < / p> < p> state pharmacopoeia committee has preliminary screening more than 500 kinds of medicinal materials, and draft of 46 kinds of quality standard < / p> < p> 'qi effectively incident' to pharmaceutical excipients that long-term marginalized, the development of the industry in confusion on the front desk, now the chaos of the industry development is expected to improve soon.
< / P> < P> the China business news has learned from parties that regulations for pharmaceutical excipients industry will be developed in the near future, including the pharmaceutical excipients registration measures for the administration and revise the medicinal materials quality standards.
< / P> < P> 'two are doing work, registration measures for the administration is expected to be introduced in July this year.
'Long-term concern of medicinal materials industry in sichuan province food and drug administration policy, law office director Song Minxian told reporters.
< / P> < P> at the same time, the national pharmacopoeia committee has been working to revise quality of medicinal materials, the first batch of 46 species of medicinal materials is now solicit opinions from the quality standard to the enterprise.
Regulatory almost blank < / P> < P> < / P> < P> according to Song Minxian, domestic pharmaceutical excipients industry due to a late start, compared to drug substances and drug products, due to a lack of unified quality standard, production enterprises of different enterprise production of the same products, the same difference in different batches of product quality, use of fake materials.
< / P> < P> in addition, in March this year by the state food and drug administration, the pharmacopoeia committee and the international association of pharmaceutical excipients pharmaceutical excipients security applications meeting, the national agency pharmaceutical excipients industry are pointed out also the lack of a series of regulatory problems: national laws and regulations of mandatory failed to reach the designated position, the quality of the pharmaceutical preparations production enterprise responsibility and suffering consciousness is weak;
Pharmaceutical excipients standard of quality control is a large gap compared with international level, etc.
< / P> < P> although as early as in 2005, state food and drug administration began to formulate the measures for the administration of pharmaceutical excipients, and has set up a consulting companies, but have not yet issued formal regulations, and the pharmaceutical excipients production quality specification (
'Since last year, due to not compulsory certification, implementation is not ideal.
< / P> < P> 'due to the pharmaceutical excipients GMP implementation is not ideal, registration measures for the administration of is especially important, for the faster, the better.
'Song Minxian said.
< / P> < P> and attended the meeting in March anhui sunvo Yin Zhenglong medicinal materials co. , LTD. , general manager, told reporters that the national pharmacopoeia committee has preliminary screening more than 500 kinds of medicinal materials, drafted the 46 species of medicinal materials and quality standards, the other will each shipment advice to companies, finalized until 2009.
< / P> < P> management conception < / P> < P> 'in the year to register again and GMP pharmaceutical production enterprise review related work, national focus will shift to pharmaceutical excipients.
'Yin Zhenglong is expected.
< / P> < P> in Beijing pharmaceutical excipients security applications on the BBS, the state food and drug registration division zhang wei at the meeting also pharmaceutical excipients management put forward some ideas for the future.
To implement standard management excipients (
Or directory management)
And registration management methods such as mixed management model.
< / P> < P> the mixed management, is refers to the part of the oral and external use material, it has been used in food and cosmetics manufacturer
industries, can consider to implement standard management, which conforms to the national related quality standards; release or recognition
Have a higher risk of security or shall manage the registration of supplementary material should be used for injection.
In their formulation, species complex, difficult to use the same standard to control the quality of the archival filing management.
< / P> < P> shall manage the registration of complementary makings, who will take production who is responsible for the quality of the principle;
On the standard management of materials, follow the principle of who use who is responsible for the quality.
< / P> < P> link < / P> < P> pharmaceutical excipients is in addition to the active pharmaceutical ingredients (in pharmaceutical preparations
The main medicine)
Outside of the auxiliary materials, including all kinds of excipients and additives.
Because of preparation auxiliary accounts for most, thus pharmaceutical excipients has direct effects on the safety and efficacy of pharmaceutical preparations.
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