OFweek Medical Technology Network: The Drug Administration Law is the basic law for drug regulation in China. It was adopted on September 20, 1984 by the Seventh Session of the Standing Committee of the Sixth National People's Congress, and then on February 28, 2001. Revised by the 20th meeting of the Standing Committee of the Ninth National People's Congress. In early 2014, CFDA launched a revised version of the Drug Administration Law to solicit proposals from the community; this can be seen as the driving force and starting point for the national drug regulatory agencies to seek regulatory changes.
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At the 26th National Pharmaceutical Economic Information Conference, which ended in November 2014, Wu Liya of the Legal Department made a report entitled “Introduction to the Drug Administration Law Revisionâ€, introducing the latest developments in the revision of the Drug Administration Law and the whole idea. It is mentioned that in order to cope with the increasingly complex drug regulatory trends, the new Drug Administration Law intends to establish the following regulatory ideas:
Gradually decentralize and cancel the drug GMP and GSP certification system, combine the certification system and drug enterprise access standards, as well as the supervision of daily production and business activities, reduce the examination and approval supervision, and strengthen daily supervision and inspection. Flight inspection is one of the most powerful of these measures.
In the "Drug Administration Law", the provisions of the recall system are explicitly added to solve the contradictions and conflicts between the lower and upper laws.
First, establish a double penalty system, and impose joint punishment measures on corporate legal persons and quality attorneys (natural persons), and establish a blacklist and prohibition system.
Second, increase the system of interviews and warning letters.
In the current transitional period, in order to ensure the stability and safety of the drug, CFDA has recently dispatched a flight inspection team to conduct flight inspections of related companies. At the same time, the National Bureau also urged the relevant provincial bureaus to increase the number of personnel and conduct large-scale random inspections and follow-up inspections of enterprises within their respective jurisdictions.
For example, on October 23, 2014, the State Food and Drug Administration (CFDA) issued a notice of flight inspections for Changchun Yuanda Guoao Pharmaceutical Co., Shaanxi Momei De Pharmaceutical Co., Ltd. and Zhejiang Qianjiang (Yucheng) TCM Decoction Pieces. Ltd. conducts investigations and penalties. According to the information disclosed by the CFDA, the problems committed by these companies are not general technical violations, but related to illegal issues, and the nature is very serious.
Beginning in November, CFDA's flight inspections and density are greater, and the regulatory trend is more stringent. Based on the information published on the CFDA website and the provincial bureaus, the author summarizes the flight inspections for 2014 as follows:
In addition, according to reliable information, at least 7 companies in China have accepted the verification and inspection by the National Bureau in accordance with the on-site verification and GMP certification combined inspection mode. This new model is similar to the foreign inspection mode, that is, no more than one inspection by an enterprise, but an inspection at the product registration stage. After the company accepts the verification and GMP certification inspection, once the approval number is obtained, it does not need to accept the GMP certification inspection, but directly obtain the GMP certificate.
From the above changes in these regulatory methods, CFDA is trying to combine the revision of the Drug Administration Law to change the previous regulatory model, replacing the previous re-approval and light supervision management mode with a high-intensity and effective daily supervision mode.
News: Re-approval of light supervision GMP certificate or cancellation for pharmaceutical companies