Medical network on March 28 - recently, sending two reference preparation to the CFDA directory, accelerated the consistency evaluation of promising industry. But it really can play a role? Not necessarily... 

 

Released on March 17, 2017 CFDA generic reference preparation directory (first batch), involving 34 species 51 gauge. 

 

Released on March 20, 2017 CFDA generic reference preparation directory (the second), involving 21 varieties of 33 product rules. 

 

Together, a total of 43 varieties 84 product rules were announced. Based on reference preparation from American Orange Book product, a total of 13 19 gauge. The original imported products, a total of 34, 53 rules. Source of Japanese products of Orange Book 1, a gauge. The rest are from the listed products in the European Union. 

 

Reference if purchase according to the sources of note of the country to buy, namely the Orange Book source is bought in the United States, the original import in domestic to buy imports, so the original imported first, optimizing the original import. The biggest difficulty is that the original imported drugs already may have recommended the CFDA property, according to rules released CFDA previously, property of the imported drugs also want consistency evaluation, this means that if the property of the imported drugs a day without consistency evaluation, the corresponding generic drug products may can't find the reference preparation. This means that the class as a generic drug products may all consistency evaluation. 

 

Table 1 the first and the second batch of generic reference preparation directory 

 

Information source: V3.2 salty reach information 

 

Here is not poking fun at nitroglycerin sublingual tablet be 0.5 mg, 0.5 mg, incidentally is not poking fun at the CFDA on March 22, 2017 haven't sneak in link attachment changed specifications of good style of work. 

 

From the CFDA will each drug corresponding reference preparations each specification is listed, you can see, the CFDA might prefer to and the same product specification for reference, not as the FDA choose the highest specifications were compared. 

 

4 days after issued two consecutive batch directory, to evaluate the consistency in from the side reflects the CFDA push urgently. After all, since 2015, the administration of the CFDA has been called on all major domestic generics firms began to actively participate in the consistency evaluation, however, CDE recently released the 2016 annual drug approval report mentioned in the 2016 declaration of generics consistency evaluation BE put on record only 16. 

 

Near the end of 2018 and 2 years time, 289 must be finished by the end of 2018 the number of varieties have launched project directory consistency evaluation is not optimistic. 

 

From the reference preparation condition of enterprises for the record side can understand various production enterprise preference for consistency evaluation project. Salty reach data V3.2 is enterprise registration reference preparation up to 20 products with the first batch of generic directory available reference preparations, now only four products before the CFDA the published two batches of generic directory reference preparations, simvastatin tablets, clarithromycin tablets, loratadine tablets and maleic acid enalaprilat slices. Thus, even if the CFDA deliberately through information sharing mechanism to promote consistency evaluation, however, the published reference preparation fails to meet the needs of larger competitive products. 

 

Table 2 companies announced record reference preparation up to 20 products reference preparation 

 

Information source: V3.2 salty reach information 

 

conclusion 

 

Progress bar is over a quarter in 2017, now the CFDA only the reference preparations, in 2018 by the end of the first directory can be finished on consistency evaluation? 

 

Generally think that has been in the United States, the European Union, Japan visual should domestic manufacturer of generic drugs already on the market to get the consistency evaluation by the end of 2018. The rest of the project, can only see the final project can endure too clinical data verification and establish a review of the batch. 

 

Consistency evaluation project at 10 million yuan, if the provinces reward 1 million yuan, the enterprise and the funding gap of $9 million. From the point of the input and output, business investment market no smaller niche product consistency evaluation. This means that 289 directory there will always be consistency evaluation products should not be completed. 

 

In addition, is expected by the end of 2017 there will BE a large number of BE test online, the clinical test units will face congestion, CRO agency again in a hurry to catch the quality, project quality is clinical data review and want to make a document number. 

 

Those who need to do in the short term the specification change is the form of a drug clinical trial products market is likely to give up the hospital, turn to a pharmacy market. But such formulations product specification change is, after all, still faces again register policy risk, very possible will not be registered again, thereby losing production approval documents.