Does the registration of drug Commissioner require postgraduate entrance examination?

Suggest postgraduate entrance examination. First of all, there is no so-called "drug registrar", only "drug registrar".

Drug registration refers to the examination and approval process in which SFDA systematically evaluates the safety, effectiveness and quality controllability of drugs to be listed according to the application of drug registration applicants, and decides whether to approve their applications. On the one hand, the work undertaken by the "registered applicant" refers to filling in, translating, sorting out, reviewing the application materials and submitting them to the drug regulatory authorities in accordance with legal procedures; On the other hand, it accepts the policy training provided by the drug regulatory authorities, establishes corresponding contacts with them, and timely feeds back the information, policies and results of drug registration to the top management of enterprises; Whether the applicant's work is completed or not, the quality is good or bad, which is directly related to the interests of enterprises, as well as the health and even life safety of the people.

Review and submit drug registration materials, declare in time according to procedures, and cooperate with drug regulatory authorities to handle relevant procedures; Follow up the progress of drug registration, so that the registration application can be successfully approved;

Through various channels, grasp the drug registration policy and variety dynamics, and handle drug registration in time; Or put forward administrative reconsideration or administrative litigation for improper registration to safeguard the interests of enterprises;

To undertake the propaganda task of drug regulatory policies and regulations, provide information on drug regulatory policies and regulations to all departments of enterprises, provide good suggestions for enterprise decision makers, and stop illegal acts in time;

Provide information support for enterprise sales, timely feedback the comparison between the declared varieties and similar varieties on the market to the marketing department of the enterprise to help it formulate and adjust sales policies;

Put forward the guiding opinions on the integration of drug research and development with international standards, and on the basis of fully understanding the internationally recognized standards formulated by ICH, combine this standard with enterprise production according to their own reality;

Design the most suitable drug intellectual property protection scheme for enterprises, so that the market occupation period and patent protection period of products can be perfectly combined.

Education and training: Drug registration is a highly professional job, which requires drug registrants to be involved in pharmacology, pharmacy, biochemical pharmacy and other fields, and generally requires bachelor degree or above in pharmacology and pharmacy.

Work experience: Have a full understanding of laws and regulations. In addition to being familiar with the Drug Administration Law and the Measures for the Administration of Drug Registration, it is also necessary to have a full understanding of other relevant and even non-drug legal provisions, such as the Measures for the Administration of Drug Import and the Law on the Protection of Intellectual Property Rights. Good communication and coordination skills. Familiar with the workflow of SFDA, Institute for Drug Control and Customs, able to communicate with them at high speed and effectively. In addition, more and more enterprises, especially departments with more transnational business, require employees to have strong English listening, speaking, reading and writing skills to meet the needs of imported drugs and international clinical declaration business; Skillful use of computer office software has also become an indispensable basic condition in the information age.

To be a drug registration Commissioner, we should start with the Measures for the Administration of Drug Registration and understand the relevant guiding principles and regulatory requirements. The basic laws and regulations include the Drug Administration Law and the Regulations for the Implementation of the Drug Administration Law. In addition, you need basic computer operation, Internet access, downloading required software from the websites of the US Food and Drug Administration and local food and drug administrations, editing basic text and table files with office software, and handling simple pictures. Have certain communication and coordination skills, because registration is the process from enterprise research and development to listing, and it is necessary to coordinate the company's materials, production, technology, quality and other departments to help complete the corresponding research, and cooperate with the teachers of the Institute for Drug Control and the Food and Drug Administration to complete the examination and approval work before listing, and there are many details to be mastered.