Explore the establishment of China Pharmaceutical Excipients DMF system / map

"As pharmaceutical excipients on drug quality andas complex, difficult to implement registration
safety is important, drug regulatory departments inmanagement. In addition, the implementation of
China have been imposed registration andadministrative examination and approval system for
management, registration management of theregistration costs.
Pharmaceutical Excipients play a strict supervision ofFor the establishment of a scientific and effective
the industry, an important role in normal development,system of medical material management, the National
but there are some, such as high cost and otherBureau in recent years, drawing on experiences of
drawbacks of the executive. "few days ago by thedeveloped countries, based on the attempt to establish,
Pharmaceutical and Biological Products of Chinapromote and improve the practice of medicine in China
organized the" 2009 Auxiliaries and Medical Packagingfor raw materials, management systems registration
Quality Control Technologies International Forum ", thefor the record, that DMF system. DMF refers to active
State Food and Drug Administration drug registrationpharmaceutical ingredients, excipients, direct contact
Secretary, said Zhang Wei, China is exploring thewith drugs Packaging materials And containers,
implementation of pharmaceutical excipients in DMFchemical intermediates manufacturer, in accordance
(registration and filing of medicinal raw materials)with the provisions of the information requirements and
management system, the system is expected toprocedures, their production processes, quality
strengthen the preparation manufacturer of the rawstandards, process parameters and quality indicators,
materials of the audit responsibility to raise the level ofand all other technical information, voluntarily submitted
the technical review of the accessories and efficiency.to the State Food and Drug Administration for drug
HC pharmaceutical industry network with mapsupervision management and pharmaceutical
Accessories in the amount of preparation in manyenterprises in the drug registration process and the
types of complicated auxiliary own safety, uniformityproduction supervision process technology used
of quality accessories, supplies and accessories anddocument management system. Zhang described the
the interaction between the active components ofdrafting of DMF system, since 2002, as China - one of
drug interaction between the quality of preparationCanada Drug Cooperation, the State Council began to
was obvious. To this end, the State Board to the Stateexplore the DMF system, and the establishment of the
Department retains the right accessories to implementdrafting group, the group by the technical review,
registration management. June 2004 the State Councilregulatory authorities, industry associations, etc. form
issued "The State Council approved the projectand involves a wide range. Held every year since the
Necessary administrative decision of an administrativerelevant seminars, in-depth study technical issues
license" (State Council Decree No. 412), the documentrelated to DMF. DMF in the international system based
legally established practice of pharmaceuticalon the full study, in March last year, the drafting group
excipients legitimacy of regulatory approval. In 2005,completed the first draft of China's DMF system. Last
the State Council issued the "PharmaceuticalNovember 19 and 28, the drafting group meetings
Excipients registration requirements for disclosure ofwere held with business representatives to discuss the
information", the new Pharmaceutical Excipients, importwork has been completed. DMF system
medical supplies, medical accessories have nationalOn the idea of establishing the time, Zhang said, the
standards, national standards have been Hollowbasic framework of the system, management
Capsule , Medicinal gelatin capsules with gelatin andmethods and international standard consistent with the
supplementary application and re-registration of the sixmode, but also adhere to the voluntary reporting, and is
major items of medical supplements standardizeddivided into public and private parts, no real review and
requirements for disclosure of information.the implementation of approval holder authorizing the
"Through the introduction of registration management,use of, the principles of change to be updated.
China's pharmaceutical industry continues to standardManagement includes Medical Packaging,
accessories, and growth of production technology andpharmaceutical excipients. Managed all the relevant
management continuously improve quality standardsinformation the applicant to the drug regulatory
continue to improve, greatly promoted the Medicinedepartments to voluntarily register for the record, the
Development of the industry. But in practice, there areopen part of the preparation of information for
some issues can not be ignored. "Zhang stressed that,enterprises choose to use raw materials, non-public
above all, blurred preparation excipients used in thepart of the information for the drug regulatory
audit of corporate responsibility, preparation ofdepartments in the preparation inspection approval and
production enterprises as the main responsibility of themanufacturers use. DMF system
selected excipients not reflected in the approvalOn the advantages and objectives, Zhang believes
system, preparation companies often evade thethat "the most obvious advantage is to strengthen the
responsibility for auxiliary enterprises and thepreparation of raw and auxiliary materials, the use of
implementation of approved manufacturing Drugcorporate responsibility." Agents manufacturing
Administration departments. Second, the accessoriesenterprises should be raw and auxiliary materials
manufacturers do not want to detailed technicalselected for the real responsibility principal, agent
information to the agent enterprise reporting, and drugbusiness can be directly referenced DMF file number,
departments in the preparation of the review processso to promote its focus on supplier auditing. In addition,
can not perform a detailed review, can only rely on theDMF system divided into two parts and private parts,
approval documents, but not many Pharmaceuticalso that technical information can also prevent leakage,
Excipients approval documents. Third, the productionensure that enterprises provide real technical
site inspections and GMP inspections limited toinformation. Goal of establishing this system is the first
registered API And the preparation of enterprises andtechnical review services, to improve the technical
the lack of actual production by the extension ofreview of the auxiliary level and efficiency. And then
auxiliary materials, raw materials, production processesfor the on-site inspection and GMP inspection services,
Drug Quality Impact of poor control, poor drug qualityincreasing the level of variety as the center of the
traceability of responsibility. Fourth, hindered the use ofinspection, to establish the true source and the whole
new accessories. Accessories manufacturers mostlyprocess of monitoring the implementation of a real
Chemical industry Enterprise, a small proportion ofsystem of inspection, improve the controllability and
Pharmaceutical Excipients, businesses time and moneytraceability. Meanwhile, companies choose to meet the
do not want to register a higher cost of declaration, itrequirements for the preparation of raw and auxiliary
has been registered for approval of supplementarymaterials, services, increasing the company as the
material has been used in China is far less than thecore of the main agents of responsibility.
accessories. Fifth, the premixed formulation excipients