[hot] one picture reading - hot spots of policies and regulations in the near future

Great companies don't look down on information about policies and regulations Sun Tzu's art of war says, "know yourself and know your enemy, and you will never lose a hundred battles." confidant is as important as knowing your enemy Great fighters will not despise the collection of intelligence information The best way for pharmaceutical companies to "know the other" is to pay attention to the policies and regulations of authoritative institutions Consistency evaluation, two vote system and other policies are related to the life and death of pharmaceutical enterprises In the 289 directory of consistency evaluation, 5409 enterprises gave up the evaluation, which means that nearly 40% enterprises chose to give up On April 26, 2017, CFDA issued the "management measures for medical device standards", and how many medical device enterprises have a headache? If we do not pay attention to international policies and regulations in time, the disaster will not be far away Data mining and visual editing mine a large number of policy and regulatory information through pharmaceutical intelligence data to form the following visual pictures for the audience to understand The larger the font, the more popular it is, and the smaller the font, the less popular it is Data mining, data visualization and other technical means can help the head of pharmaceutical companies or market departments to understand domestic and foreign policy hot spots in the shortest time, and adjust strategies to adapt to policy changes in a timely manner CFDA: in 2016-2017, the visualization of hot spots of policies and regulations first looks at CFDA The figure above shows the largest font of medical devices This shows that there are many policies and regulations issued by CFDA in recent years According to the statistics of small compilation, the relevant regulations of medical devices have accounted for 24% of the total number of regulations since 2016, with a large proportion (as shown in the figure below) By querying the database of drug and intellectual policies and regulations, the recent regulations on medical devices are as follows: on August 9, 2017, CFDA issued one of the interpretations of the measures for the management of medical device standards, and the second of the interpretations of the measures for the management of medical device standards; on July 31, 2017, CFDA issued the interpretation of the issues related to the quality management of clinical trials of medical devices; On April 26, 2017, CFDA issued the measures for the administration of medical device standards (Order No 33 of the State Food and Drug Administration) The effectiveness level belongs to laws and administrative regulations Article 32 the technical committee of medical device standardization shall track and evaluate the implementation of the standards, and the medical device standard Management Center shall carry out the implementation of the mandatory standards according to the tracking and evaluation Statistical analysis This article makes many medical device enterprises can't bear it, because the products produced in the future should meet the statistical indicators in the relevant national standards, otherwise they will not be able to bear it In recent years, the policies and regulations of CFDA for medical devices are quite popular, rather than being written casually, but the social needs In recent years, there are many substandard products of medical devices exposed, and there are a lot of chaos, and the quality of medical devices is related to the safety of people's lives Therefore, CFDA issued more medical device policies and regulations to let enterprises strictly control the quality of devices FDA: 2016-2017 policy and regulation hot spot visualization EMEA: 2016-2017 policy and regulation hot spot visualization editor through the recent policy and regulation visualization analysis of the US Food and Drug Administration (FDA) and the European Community Drug Review Committee (EMEA) (as shown in the figure above), found that be and bioequivalence fonts are large Be is the abbreviation of bioequivalence, indicating bioequivalence It seems that recent bioequivalence tests in the United States and Europe are hot spots It may be affected by FDA and EMEA, and the conformity evaluation of domestic generic drugs is very popular Bioequivalence (be) refers to the statistical difference in the absorption degree and speed of the test preparation and the control standard preparation under the same test conditions When there is no clinical significance in the difference of absorption rate, bioequivalence can be considered for some drugs with the same absorption degree and different absorption rate Bioequivalence is different from pharmaceutical equivalences Pharmaceutical equivalency refers to the preparation that the same dosage of the same drug is made into the same dosage form, but the inactive ingredients are not necessarily the same, and the content, purity, uniformity, disintegration time and dissolution rate of the same drug meet the standards specified in contract 1 The drug equivalence can not reflect the situation of drug preparation in vivo Generally speaking, many indicators of generic drugs should achieve the same effect of the original drugs If the bioequivalence test fails, the generic drugs will not be available in the market It's hard for a group of pharmaceutical companies It takes millions of money to play be, and it's going to be over before it's over How to play be, you can consult the authoritative expert of Medicine intelligence for free interpretation Original statement: This article is the original manuscript of yaozhi.com, welcome to reprint, reprint please indicate the source and author, thank you!