At the end of 2017, there is a full year of the “consistent†2018 consistency evaluation. At present, many companies have claimed to have completed the consistency evaluation, or claimed that the first, whether true or false, at least CFDA or CDE has not clearly announced that a certain family has passed the consistency evaluation, and other people think about it.
Generic drug
The varieties that have passed the consistency assessment are not in the scope of our discussion today. Today is to say that at the end of 2018, those companies that are very likely to fail to achieve consistency assessment, how to break through?
Because the declaration at the end of 2018 requires one year of stability data, there is not much time left for the company. Now that there is no stability sample, you can say it responsibly, basically failing to declare at the end of 2018.
Why can't catch up, think about it, just for the following reasons: policy, personnel, technology, management and other factors, and if the company wants to break through, the corresponding enterprise solutions also listen to me.
The erratic guide & lagging policy
Enterprises need to correctly analyze and do risk prevention and re-action
Beginning with an article, in June of this year, the article “From the Azithromycin Tablets to the Reference Groupâ€, this article spurred the circle of friends, sparked a big debate in the industry about the choice of reference preparations. implied in the text:
In the third batch of reference preparations published by the CFDA on April 27 this year, the reference to this specification is TevaPharmaB.V. "Azitromycin 250TEVA", which is listed in the EU, is produced in Croatia.
Before the 0.25g azithromycin tablets, the manufacturers almost uniformly pressed the reference treasure to Xi Shumei of Pfizer. Do not believe? Let us look at the information on the reference preparations published by the Central Prosecutor's Office on April 27th, as of April 20th. A total of 43 reference preparations for 0.25g azithromycin tablets are PHI's Xi Shumei (without exception). Pfizer companies of all countries)
Oolong went out to sea, causing a thousand waves!
The choice of reference preparations once made the company very passive. The General Administration of the People's Republic of China on March 18, 2016, issued a notice on the selection and determination of three technical guidelines for the selection and determination of common oral solid preparations (No. 61, 2016), which clarifies the selection criteria for reference preparations. Which mentions:
The pharmaceutical production enterprises shall carry out preliminary research according to the task requirements of the national generic drug quality and efficacy consistency evaluation and the situation of the varieties to be evaluated, and prepare the reference preparations for reporting to the consistency evaluation office. If the Office of Conformity Evaluation does not raise an objection within 60 working days, the company can carry out relevant research work. â€
I believe that many companies have received phone calls, said that they have filed a case, and they can conduct research; or they can conduct research without receiving a call. A company selected Japanese or American reference preparations, spent hundreds of thousands of goods from the reference suppliers, and finally announced the products of a small European country. Moreover, the reference preparation is imported at one time. The provincial bureau is not clear how to handle the approval. The customs is not clear how to declare it. Is there any wood?
After a lapse of 8 months, on November 29, 2016, the General Office of the General Administration of the People's Republic of China publicly solicited opinions on further guidance on the quality of the generic drug and the consistency of the evaluation of the reference formulation. The reference preparation was basically finalized.
The other thing is to waive the release of the BE variety. The CFDA has issued the exemption guidelines. Suddenly, the first exemption list has come. Is the variety that was already prepared for BE, are they all imagining? After all, the bioequivalence test of a subject of tens of thousands of yuan is not a small amount for the enterprise.
PS. I didn't mean the bad words of CFDA, so I hope I don't want to be put on a hat. The author knows that the CFDA is good and only hopes that the pharmaceutical industry is better!
Halal Empty Capsule,Halal Empty Gelatin Capsules,Empty Capsule Shell With Halal,Halal Shell Empty Gelatin Capsules
Ningbo Jiangnan Capsule Co., Ltd. , https://www.jncapsule.com