CDE Meeting Minutes: Differences in Drug Risk Management in the U.S. and Europe

the original title: "CDE Meeting Minutes" Sino-American Drug Risk Management Differences
"Celgen Company Product Risk Management Experience Seminar" meeting minutes
November 6, 2008, some of the center's reviewers and the United States Celgen company principals and their related experts on some of the company's products in Europe and the United States risk management model and experience and other topics of mutual interestThis exchange, our reviewers from the specific operational perspective of variety risk control in the United States and Europe risk control planning and implementation of a relatively in-depth understanding, the company's experts also have a basic understanding of the risk control in our technical reviewaccording to the meeting schedule,, the purpose of the seminar is mainly to share Celgen's successful control of thalidomide (also known as "reaction stop") and Lenalidomide in the United States market safety risk experience, in understanding its risk control plan management model, practical operation content, effectiveness assessment methods, management technical review model and other specific information based on the broad exchange of China's national conditionsthalidomide, a legendary and controversial drug, was praised by the FDA in the 1960s for refusing to list it in the U.S., but approved it late last centuryThis listing approval for thalidomide is intended to treat moderate to severe lepronosy erythema (ENL), which can also be used to prevent and reduce the recurrence of ENL, but the black box warning indicates "severe, life-threatening birth defects." Similarly, as a thalidomide analogue analogue, Tonala is approved for the treatment of blood transfusion dependence anemia caused by a 5q missing chromosomal abnormality or no other chromosomal abnormality due to a low-risk or critical bone marrow hyperplasia syndrome, with a black-box warning indicating "1potential lyphory possibilities;the FDA's ability to treat thalidomide and inamine with a safe pregnancy rating "X" have very different treatment outcomes over different historical periods, the key is that the two drugs are ultimately conditional lying based on risk managementThrough the exchange, Celgen company in the world according to the national conditions of different listed countries or regions to take two main risk management models, one is north America and Australia model, followed by the European Union and Latin America modelThe former is mainly based on a strict management system for drug distribution, in which pharmaceutical companies play a key leading role, the latter is mainly through the expansion of risk communication and the adoption of risk minimization measures, such as black-box warnings, labels, drug guidelines, patient instructions, letters to dear doctors, health advice, educational forums, questionnaires, sales promotion, pharmaceutical companies only indirectly involvedOn the basis of the EU and Latin American model, the Australian-American model, the use of registration system to further focus risk management on the patient, prescription and pharmacy of the three circulation of the use of the monitoring, first, the prescription and pharmacist must be through special training, followed by the use of patients need to strictly control the use of the indications, and fully inform the adverse reactions to that degree of amine and medication dose, daily life, pregnancy testing and drug recovery and other medication precautions, after doctors, pharmacists confirmed the treatment of patients may also be given a questionnaireThroughout its use, Celgen is involved in the regulation, communication and collection of relevant information for the drug, as well as regularly analyzing the correlation between the drug and adverse events and reporting it to the FDAThe main means of this regulatory model is to rely on computer systems to do so, and of course by means of fax, telephone and correspondence questionnairesFrom above, it is clear that whether it is the Safe Prescription and Education Program (S.T.E.P.S) or the Safe Prescription and Physician Patient Education Program (REVAssist), its effective risk management is based on high-cost maintenance costs and therefore a greater burden for healthcare professionals, pharmacists, patients, and businesses"Of course, the premise of implementing this high-cost risk management is that the firm considers this input/output ratio to be worthwhile by weighing it." we also learned during the exchange that the European and American requirements for dealing with risk management programs are also different, for example, the EU requires all NDAs to submit risk management plans, and the FDA only requires varieties with serious safety concerns to submit risk management plans, such as potential teratogenic drugs China is currently somewhat similar to the FDA, only requires high-risk categories of varieties to submit risk management plans, but the FDA does not simply determine by drug category and new and old are high-risk products, to specific products to be specific analysis Therefore, if implemented as required by our special review procedures, we may be involved in a larger variety than the FDA The cost of implementing risk management in a Western way may be unimaginable referring to risk management and technical evaluation of pre-market research, Ms Florence, a former CDER/CBER review officer, said that it is difficult to evaluate the effectiveness of risk management plans solely on pre-market research, and that strengthening drug safety assessments requires continuous digging of data on the life cycle of the drug market, and that repeated revision of risk management plans can be used to effectively manage risk The FDA requires companies to be responsible for risk management and to report to regulatory authorities on a regular basis in the implementation of the risk management program In addition, the FDA also carries out corresponding internal reforms from the management mechanism and management measures to adapt to, such as in accordance with its FDAAA2007 requirements, in the event of an unconventional risk category, should be implemented risk assessment and mitigation strategy (reimator(formerly known as RMP), change the product safety label or conduct clinical research risk assessment During the talks, the two sides also discussed specific drug alert analysis methods, which are not detailed here Through this discussion, we basically understand the risk management model of major developed countries and regions, share the practical experience of Celgen to control risk, but also bring us thinking and more enlightenment: 1 Drug risk management is not only related to pre-listing registration supervision, more importantly, further supervision after listing, so we need to fully understand the organization and division of labor of the supervisory bodies, 2 Risk management for the domestic industry is A relatively unfamiliar subject, whether it is model, concept, talent, capital or technical methods are relatively lacking, many also need to combine with the national conditions to step up research, to explore our basic model ; Innovative drugs should be a category of drugs worth trying However, it does not seem to be general, considering a choice and focus in the light of our basic risk management requirements (and the size of the costs involved), the size of the risk exposed to the product, and the degree to which the indications are accepted of the risk (a trade-off of the pros and cons) Because risk management is bound to lead to increased costs of new drug production and operation, the contradiction between economic costs and treatment costs for a developing country such as our country, management has to consider additional; 5 For the management organization, in addition to the revision of the manual, recall, withdrawal and other classic risk management means, it is urgent to develop other effective risk management means, such as doctor patient education, registration system, risk control effect assessment, etc., to give full play to the role of enterprises in risk control extended the planned one-and-a-half-hour meeting to three and a half hours in a frank and friendly atmosphere In this exchange, the practical experience shared by Celgen provides us with a wealth of first-hand information for thinking and studying the risk management in China's drug registration process, as well as an effective way and platform for regulators to discuss and solve risk control problems between the regulatory authorities and 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