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Generic drug quality consistency evaluation work plan
Generic drugs are alternative drugs with the same active ingredients, dosage forms, routes of administration and therapeutic effects as generic drugs, and have important economic and social benefits such as reducing medical expenses, improving drug accessibility, and improving medical service levels. Due to the relatively weak foundation of early-approved generic pharmaceutical research, the quality of some generic drugs is far from that of generic drugs, and the clinical efficacy of generic drugs cannot be achieved. Improving the quality of generic drugs is of great significance for maintaining public health. The National Twelfth Five-Year Plan for Drug Safety clearly stated that it will take 5 to 10 years to conduct a comprehensive comparison study on generic drugs before the implementation of the revised Drug Registration Regulations in 2007. To make the generic drug consistent with the generic drug. In order to implement the relevant requirements of the National Twelfth Five-Year Plan for Drug Safety, this work plan has been formulated.
I. Work Objectives The quality consistency assessment of generic drugs is organized by the State Food and Drug Administration to organize relevant technical departments and experts. The self-assessment data of generic drugs proposed by pharmaceutical manufacturers shall be evaluated according to the given evaluation methods and standards. Generic drugs have a consistent process of intrinsic material and clinical efficacy. Through the consistency evaluation of generic drugs, it is necessary to eliminate the varieties whose internal quality is not up to the requirements, and promote the overall level of generic drugs in China to reach or approach the international advanced level.
Second, the working method
(1) Piloting first, then pushing forward, and gradually advancing. Select the basic drug list, the market share is large, the market sales are large, the production enterprises are many, and the varieties of the original research enterprises are tested first, the experience is accumulated, and then gradually pushed forward, comprehensively promoted, and gradually improve the quality evaluation system of generic drugs, and build the quality of drugs. Improved working mechanism.
(2) Classification and processing by scientific and reasonable technical methods. Based on the principle of scientific rationality and classification, the quality consistency evaluation of generic drugs is combined with the improvement of drug standards and evaluation work, and is carried out step by step according to the nature of the drug and the characteristics of the drug dosage form. First, the consistency evaluation of oral solid preparations was carried out; secondly, the consistency evaluation of injections was carried out; finally, the consistency evaluation of other dosage forms was carried out.
Third, job responsibilities
(1) The State Food and Drug Administration is responsible for the organization and implementation of the evaluation of the quality consistency of generic drugs. Organize the development of a generic drug quality consistency evaluation work program, issue relevant evaluation methods, standards and technical guidelines, and organize the review of the conformity evaluation materials submitted by pharmaceutical manufacturers. The State Food and Drug Administration will set up a special office to be specifically responsible for this work.
(2) The provincial drug supervision and administration department is responsible for the organization and coordination of the evaluation of the quality consistency of generic drugs within its jurisdiction. To undertake the implementation and publicity of the quality consistency evaluation of generic drugs, and urge the drug inspection agencies within the jurisdiction to complete the tasks undertaken on time, in accordance with the consistency evaluation work deployment and cooperate with relevant training, and accept the acceptance and production of the conformity evaluation materials according to the requirements. On-site inspection and sampling inspection.
(3) The pharmaceutical production enterprise is the main body for the evaluation of the quality consistency of generic drugs. In accordance with the unified deployment of the State Food and Drug Administration, in accordance with relevant technical guidelines, evaluation methods and standards, comprehensive and in-depth comparative research with generic drugs should be carried out to solve the key problems affecting the intrinsic quality of generic drugs, and to achieve Consistent in terms of intrinsic material and clinical efficacy.
The reference preparation manufacturer shall, in accordance with the requirements of the State Food and Drug Administration, cooperate with the drafting of evaluation methods and standards, as well as the supply of reference preparations.
Fourth, the work content
The quality consistency evaluation of generic drugs is mainly for basic drugs and common chemic
2018-12-18
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Tao Jianhong talks about how to do a good job in market analysis of new drug research and development projects
The "beautiful philosophy" of Chinese-style innovation
“No one can assert that pharmaceutical innovations in opportunities, cooperation, transformation and complex global competition will eventually go where. But we know that history does not look back; no one can predict, in wealth, policy, technology Under the combined effect of culture, there are still many potentials for pharmaceutical companies to be stimulated. We only know that the future is always beyond imagination!" Tao Jianhong, deputy director of the Southern Institute of Pharmaceutical Economics and editor-in-chief of the Pharmaceutical Economics News, in an interview Ruan Dalai: "The innovative thinking in the development of new drugs, on the premise is a speculation on market demand, the market will rebut this round of conjecture. Those after a round of market defense, and constantly revised, What is finally surviving after adjustment is the truly productive innovation." So, how can we connect the test tube to the counter with the shortest time and the lowest cost? Let us share Tao Jianhong's "beautiful philosophy" about the development of new drugs.
The ability to keep thoughts happy
Reporter: What changes are taking place in the current environment of new drug research and development at home and abroad?
Tao Jianhong: At the moment, all countries in the world are looking for an industrial restructuring path that is out of the economic dilemma. Innovation is known as the vitality engine that drives sustainable development. How to keep innovative ideas and research and development practices fresh is a difficult problem. We are all familiar with the story of Don Quixote, the paranoid ideal, the personality that is not afraid of sacrifice, and somewhat similar to those who are lonely in the innovation adventure. However, innovation does not welcome sad heroes. The most important quality of scientists is optimism and tenacity. We must understand the enjoyment of drug research. The first decade of this century is the “lost decade” of global drug research and development – the pharmaceutical industry once entered a period of high investment and low output, and the value of each industry invested in research and development has shrunk by 70%. 2005~ In 2010, the number of approved NMEs fell by 40%, the number of NMEs approved by the FDA for listing each year was only 22, and the value of new drugs listed was only $430 million, down 15% from the last 10 years of the 20th century. With the expiration of patents such as Lipitor, the total value of pharmaceutical companies has shrunk by more than $50 billion. In addition, the global pharmaceutical industry is still in a relatively monopolistic situation of leading companies in a few developed countries. The weakening of innovation in large companies has lowered the overall growth rate of the pharmaceutical economy. In the next three years, the growth rate of the world pharmaceutical market will remain at 5%. about.
Fortunately, we began to recover the “lost decade”, and the global climate for drug innovation has recovered. In 2012, the top ten research and development strengths of the global pharmaceutical industry were 15.5% on average, maintaining the usual level, especially In the emerging market countries such as China, the investment in R&D has increased. According to estimates by the South, during the “Twelfth Five-Year Plan” period, China’s drug R&D investment has increased by nearly 20.8 billion yuan annually, and the R&D intensity reached 3% in 2015.
In 2013, two major policies will bring positive energy to new drug research and development. More direct is the reform of the drug review system. We noticed that the 2012 drug review report disclosed recently changed the stereotyped official document writing style. At the beginning, it used the voice of humanistic care and described the “reaction stop” incident. It reveals the powerful mission of new drug approval for defending health, and makes the seemingly mysterious drug review close to the public. At the end of 2012, Guangdong Province first tried, new drug technology transfer, drug production technology transfer and some inter-provincial drug commissioned production business have been technically reviewed and administratively approved in the provincial bureau. The National Drug Evaluation Center has established a pre-clinical pharmacy evaluation template for innovative drugs and an annual reporting system during research and development. The technical requirements for pharmacy are basically in line with international standards. Interpretation of relevant reforms, our "Pharmaceutical Economics" will be presented with thematic planning.
Another far-reaching impact is the national “12th Five-Year” bio-industry development plan. The 21st century is an era dominated by life sciences. China's life sciences industry has a large number of experienced technical talents and attracts the attention of venture capitalists. The Chinese government's suppo
2018-12-18
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36 drug registration supplementary application fees, item by item price list!
With the release of new drug registration fees, the new drug registration fee and generic drug registration fee are clearly understood. For the supplementary application fee, it is a little dizzy. First, the number of supplementary applications has reached 36. Second, the same supplementary application may also have conventional items and technical review items, and the charging standards are very different.
Drug registration fee
Note: 1. The drug registration fee is calculated based on one drug substance or one preparation. If another specification is added, the registration fee will be increased by 20% according to the corresponding category. 2. In the "Administration of Drug Registration", the drug supplement application filed by the provincial food and drug supervision and administration department or directly filed by the food and drug supervision and administration department of the State Council does not charge for the supplementary application registration fee. In the case of review, the applicant shall pay the fee in accordance with the charging standard for the supplementary application requiring technical review.
3. If you apply for a one-time import of drugs, you will receive a registration fee of RMB 0.20 million.
4. The import drug registration fee standard is based on the corresponding domestic registration fee standard and the difference between domestic and international inspection of transportation, accommodation and food expenses.
5. The registration fees for drug registration in Hong Kong, Macao and Taiwan shall be implemented in accordance with the registration fee for imported drugs.
6. The fee for the registration of the drug registration expedited fee shall be separately formulated.
In order to clarify the relationship between them, I found the attachment of the No. 28 Order, the original remarks, and suggested that colleagues collect this article in case of emergency.
Annex 4: Registration of Drug Replenishment Application and Application Requirements
a), charging matters
There is no free lunch in the world! And now the charge is not cheap! The starting price (so-called regular item) starts from RMB 0.96 million, and the technical review item needs RMB 96,000. The entire first registration item requires money, and the note is charged. In the future, every time the boss says that he wants to change, remember to remind him how much it costs!
I. Registration matters
(1) Supplementary application items approved by the State Food and Drug Administration:
1. The approval number of the pharmaceutical manufacturer that holds the new drug certificate to apply for the drug. (Requires technical review, charge 99,600 yuan)
2. Use the drug product name. (conventional item, charge of 0.96 million yuan)
3. Increase the indications of traditional Chinese medicine, indications for natural medicines, or indications approved by chemicals and biological products in China. (Requires technical review, charge 99,600 yuan)
4. Change usage and dosage or change the scope of the applicable population without changing the route of administration. (Requires technical review, charge 99,600 yuan)
5. Change the drug specifications. (Requires technical review, charge 99,600 yuan)
6. Change the prescriptions for medicinal requirements in the drug prescription. (Requires technical review, charge 99,600 yuan)
7. Change the production process that affects the quality of the drug. (Requires technical review, charge 99,600 yuan)
8. Amend the drug registration standard. (Requires technical review, charge 99,600 yuan)
9. Replace or subtract the toxic substances in the national drug standard prescription or the drugs in the endangered state. (Requires technical review, charge 99,600 yuan)
10. Imported drugs, domestically produced injections, ophthalmic preparations, aerosols, powders, sprays, packaging materials or containers that are in direct contact with the drug; use of new packaging materials or containers that directly contact the drug. (Requires technical review, charge 99,600 yuan)
11. Apply for pharmaceutical combination packaging. (Requires technical review, charge 99,600 yuan)
12. Technology transfer of new drugs. (Requires technical review, charge 99,600 yuan)
13. Revise or increase the pharmacology and toxicology, clinical trials, pharmacokinetics and other items in the instructions for Chinese medicines and natural medicines. (Requires technical review, charge 99,600 yuan)
14. Change the registration items of the imported drug registration certificate, such as the name of the drug, the name of the pharmaceutical manufacturer, the registered address, the expiration date of the drug, and the packaging specifications. (Change the name, registered address, packaging specifications, and regular items of the pharmaceutical manufacturer, the fee is RMB 0.96 million) (Change the name of the drug, the validity period of the drug, the technical review item is required, and the fee is 99,600 yuan)
15. Change the origin
2018-12-18
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