Medical network - March 24, drop one, pharmaceutical industry has great things!
Starting from April 1 this year, including GSP, GMP certification, seven charges, all cancelled!
On March 23, ministry of finance, national development and reform commission jointly issued "about cleaning specification of a batch of administrative fees announcement concerning the policy -" notice "(hereinafter referred to as the notice) said," for the practical and easing the burden on enterprises and individuals, promote the development of the real economy, approved by the state council, since April 1, 2017, cancel or stop 41 central set up administrative fees."
▍ cancellation charges 12, involving a drug regulators are:
The certification fee. Including: drug production quality management standard certification fees, drug management quality management certification fee
The inspection fee. Include: drug inspection fee, medical apparatus and instruments product inspection fee
Anesthesia, import and export of psychotropic drugs license fee
Drug protection money. Varieties include: drug administration protection, traditional Chinese medicines protection money
As of the date of this notification issued by the ministry of finance, said.
▍ cancellation fee notes shall turn over, must not with any reason to delay or refuse to perform
In the "notice", the two ministries request relevant departments and units, shall be the financial instrument shall turn over formalities to door of ministry of finance. Shall be in strict accordance with the regulations for the administrative fees, must be cancelled, stop, or reduction of administrative fees, must not with any reason to delay or refuse to perform.
Relevant departments should strengthen the supervision and inspection of policy implementation, in violation of provisions, shall, in accordance with the "budget law", "price law", "financial illegal punishment punishment regulations" and so on dealt with laws, administrative rules and regulations.
There is no charge for decisive!
The country nearly 15 m drug companies, wholesale, retail businesses, have to say is good, especially in the current stressful situation, throttling effect is obvious.
According to national food drug administration database statistics, the total have a GMP certificate of 28171 pieces, the GSP certificate of 149169 copies, with the most conservative estimates (GMP: 30000 / piece, GSP: 30000 / sheet), just cancel the certification fees, nearly 1 billion yuan.
▍ GSP, GMP certification will be cancelled
Certification fee is not accepted, the next step may simply want to cancel the GSP, GMP certification also. This is not unfounded, as a matter of fact, officials have been release signals from the year before.
On September 20, 2016 CFDA legal department deputy director Wu Li jas in "2016" the first China drug regulatory science conference on revision of the pharmaceutical administration law are introduced, in the "key consider modify the content", refers to "appropriate to reduce the administrative licensing: cancel the GMP and GSP certification".
In march, administration officials have said: is the revised part has been in the pharmaceutical administration law basic, the GMP and GSP, GCP, GLP no longer make specific certification. But management can't lag, but also according to the provisions of standard inspection, production, circulation may be joining together of two card.
The cancel of the two ministries to certification fees, probably might be the prelude to cancel all certification. It also conforms to the current drug regulatory, authenticated by the static, into a dynamic control direction. Wide into bat, fly frequently, become a trend.
Since then, began in 2000, the new GSP certification, and in 1999 the GMP certification, or will become history.
(note: GSP certification start time to select the new standards, selection of GMP 98 revised edition. The previous version for trial)
Attachment: cancel or stop administrative fees project (the ministry of finance of the national development and reform commission)
(a) cancel the enterprises of administrative fees (12)
The food and drug regulatory authorities
16. The certification fee. Including: drug production quality management standard certification fees, drug management quality management certification fee
17. The inspection fee. Include: drug inspection fee, medical apparatus and instruments product inspection fee
18. Import and export license fee narcotic and psychotropic drugs
19. The drug protection money. Varieties include: drug administration protection, traditional Chinese medicines protection money
Add: clear about specification of a batch of administrative fees related policies and notice (caishui [2017] 20)
The central party school, including administration, ministries and departments under the state council, the high court, procuratorate, the communist youth league central, provincial, autonomous region or municipality directly under the central government departments, price bureau (bureau), the national development and reform commission, the xinjiang production and construction corps finance bureau, the national development and reform commission:
For the practical and easing the burden on enterprises and individuals, promote the development of the real economy, approved by the state council, administrative fees will now clear specification about policy are as follows:
A, since April 1, 2017, cancel or stop 41 established the central administrative fees specific projects (see annex), trademark registration fee standards to reduce 50%.
Second, the relevant departments and units shall the Treasury bills shall turn over formalities to door of ministry of finance. Previous year owes the administrative fees, fees relevant departments and units shall pay the bill in full, and according to the regulations of the financial department of the channel to the state Treasury in full.
Three, cancel, stop, or relief after the administrative fees, the relevant departments and units to perform management functions in accordance with the relevant funds, is provided by the budget at the corresponding level, shall not affect shall perform their duties according to law. Among them, the administrative units on spending and fiscal subsidy institution, shall be incorporated in the relevant unit budget guaranteed; About spending funds on their own institution, by arranging for its superior departments spending way. The central government by general transfer payments properly solve the problem of difficult areas of financial funds safeguard.
Four, the provinces, autonomous regions and municipalities directly under the central financial department under the state council in conjunction with the departments concerned to the region's administrative fees policy to conduct a comprehensive cleaning, and on April 30, 2017 report to the ministry of finance will clear specification. For projects is really necessary to retain the administrative fees, to implement a directory listing management, take the initiative to accept social supervision. To set up the central administrative fees, we will strictly in accordance with state regulations, shall not alter the collection scope, standard or charge any fee separately.
Five, all localities and departments and units through radio, television, newspaper, Internet and other media, strengthen policy propaganda, timely information release, public opinion guide.
Six, all localities and departments and units shall be in strict accordance with the regulations for the administrative fees, to must be cancelled, stop, or relief of administrative fees, and shall not be any reason to delay or refuse to perform. Relevant departments should strengthen the supervision and inspection of policy implementation, in violation of provisions, shall, in accordance with the "budget law", "price law", "financial illegal punishment punishment regulations" and so on dealt with laws, administrative rules and regulations.
Seven, this notice will come into effect from the date of printing. |
