Used Excavators

Posts Tagged ‘Explore’

“As pharmaceutical excipients on drug quality and safety is important, drug regulatory departments in China have been imposed registration and management, registration management of the Pharmaceutical Excipients play a strict supervision of the industry, an important role in normal development, but there are some, such as high cost and other drawbacks of the executive. “few days ago by the Pharmaceutical and Biological Products of China organized the” 2009 Auxiliaries and Medical Packaging Quality Control Technologies International Forum “, the State Food and Drug Administration drug registration Secretary, said Zhang Wei, China is exploring the implementation of pharmaceutical excipients in DMF (registration and filing of medicinal raw materials) management system, the system is expected to strengthen the preparation manufacturer of the raw materials of the audit responsibility to raise the level of the technical review of the accessories and efficiency.

HC pharmaceutical industry network with map

Accessories in the amount of preparation in many types of complicated auxiliary own safety, uniformity of quality accessories, supplies and accessories and the interaction between the active components of drug interaction between the quality of preparation was obvious. To this end, the State Board to the State Department retains the right accessories to implement registration management. June 2004 the State Council issued “The State Council approved the project Necessary administrative decision of an administrative license” (State Council Decree No. 412), the document legally established practice of pharmaceutical excipients legitimacy of regulatory approval. In 2005, the State Council issued the “Pharmaceutical Excipients registration requirements for disclosure of information”, the new Pharmaceutical Excipients, import medical supplies, medical accessories have national standards, national standards have been Hollow Capsule , Medicinal gelatin capsules with gelatin and supplementary application and re-registration of the six major items of medical supplements standardized requirements for disclosure of information.

“Through the introduction of registration management, China’s pharmaceutical industry continues to standard accessories, and growth of production technology and management continuously improve quality standards continue to improve, greatly promoted the Medicine Development of the industry. But in practice, there are some issues can not be ignored. “Zhang stressed that, above all, blurred preparation excipients used in the audit of corporate responsibility, preparation of production enterprises as the main responsibility of the selected excipients not reflected in the approval system, preparation companies often evade the responsibility for auxiliary enterprises and the implementation of approved manufacturing Drug Administration departments. Second, the accessories manufacturers do not want to detailed technical information to the agent enterprise reporting, and drug departments in the preparation of the review process can not perform a detailed review, can only rely on the approval documents, but not many Pharmaceutical Excipients approval documents. Third, the production site inspections and GMP inspections limited to registered API And the preparation of enterprises and the lack of actual production by the extension of auxiliary materials, raw materials, production processes Drug Quality Impact of poor control, poor drug quality traceability of responsibility. Fourth, hindered the use of new accessories. Accessories manufacturers mostly Chemical industry Enterprise, a small proportion of Pharmaceutical Excipients, businesses time and money do not want to register a higher cost of declaration, it has been registered for approval of supplementary material has been used in China is far less than the accessories. Fifth, the premixed formulation excipients as complex, difficult to implement registration management. In addition, the implementation of administrative examination and approval system for registration costs.

For the establishment of a scientific and effective system of medical material management, the National Bureau in recent years, drawing on experiences of developed countries, based on the attempt to establish, promote and improve the practice of medicine in China for raw materials, management systems registration for the record, that DMF system. DMF refers to active pharmaceutical ingredients, excipients, direct contact with drugs Packaging materials And containers, chemical intermediates manufacturer, in accordance with the provisions of the information requirements and procedures, their production processes, quality standards, process parameters and quality indicators, and all other technical information, voluntarily submitted to the State Food and Drug Administration for drug supervision management and pharmaceutical enterprises in the drug registration process and the production supervision process technology used document management system. Zhang described the drafting of DMF system, since 2002, as China – one of Canada Drug Cooperation, the State Council began to explore the DMF system, and the establishment of the drafting group, the group by the technical review, regulatory authorities, industry associations, etc. form and involves a wide range. Held every year since the relevant seminars, in-depth study technical issues related to DMF. DMF in the international system based on the full study, in March last year, the drafting group completed the first draft of China’s DMF system. Last November 19 and 28, the drafting group meetings were held with business representatives to discuss the work has been completed. DMF system

On the idea of establishing the time, Zhang said, the basic framework of the system, management methods and international standard consistent with the mode, but also adhere to the voluntary reporting, and is divided into public and private parts, no real review and the implementation of approval holder authorizing the use of, the principles of change to be updated. Management includes Medical Packaging, pharmaceutical excipients. Managed all the relevant information the applicant to the drug regulatory departments to voluntarily register for the record, the open part of the preparation of information for enterprises choose to use raw materials, non-public part of the information for the drug regulatory departments in the preparation inspection approval and manufacturers use. DMF system

On the advantages and objectives, Zhang believes that “the most obvious advantage is to strengthen the preparation of raw and auxiliary materials, the use of corporate responsibility.” Agents manufacturing enterprises should be raw and auxiliary materials selected for the real responsibility principal, agent business can be directly referenced DMF file number, so to promote its focus on supplier auditing. In addition, DMF system divided into two parts and private parts, so that technical information can also prevent leakage, ensure that enterprises provide real technical information. Goal of establishing this system is the first technical review services, to improve the technical review of the auxiliary level and efficiency. And then for the on-site inspection and GMP inspection services, increasing the level of variety as the center of the inspection, to establish the true source and the whole process of monitoring the implementation of a real system of inspection, improve the controllability and traceability. Meanwhile, companies choose to meet the requirements for the preparation of raw and auxiliary materials, services, increasing the company as the core of the main agents of responsibility.