Pharmaceutical Affairs Law edits draft submits to to discuss advanced to drug price theory outstandi

Pu Xiaolei of reporter of legal daily entire media

On April 20 morning, pharmaceutical Affairs Law edits draft submits to the 10th times the conference discusses standing committee of National People's Congress of 13 whole nations.

Give in time to the outstanding issue of existence standard, edit correction draft instead draft;

Mix high in the light of drug price theory supply the outstanding issue such as shortage, increased to strengthen medicine to valence is superintended and ensure the regulation that medicines and chemical reagents supplies;

Fulfil punishment to arrive person, direct and the legal representative of unit of drug of bad of false to be engaged in producing a sale medicine, main controller, responsible director staff and other responsibility personnel, increase to find out the regulation of criminal responsibility lawfully;

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Be aimed at the many heat problem that the public pays close attention to, edit draft made relevant provision.

Correction draft instead edits draft

Last year in October, the 6th times the conference is opposite standing committee of National People's Congress of 13 whole nations correction draft of Pharmaceutical Affairs Law undertook the first time discuss.

Some standing committee committee members, branch, expert and social community put forward, after Pharmaceutical Affairs Law edited 2001 oneself, did not undertake big modification, the first time deliberative correction draft basically is permit holder system to wait to executing medicines and chemical reagents to appear on the market make a provision, other some regulations also should taste an industry to develop to be revised further with superintendency need according to medicine perfect. The practice that suggests to reform domain of medicines and chemical reagents achievement and effective rises for law, according to medicines and chemical reagents management of whole process, entire chain asks to perfect concerned regulation, give in time to the outstanding issue of existence standard, edit correction draft instead draft. In the meantime, want to had treated the concern that runs a way with the vaccine that making.

When constitution of countrywide National People's Congress and Bin of clump of committee member of legal council vice director are making draft explain, say, committee classics studies constitution and law, the proposal is used edit means undertakes modification to Pharmaceutical Affairs Law, according to medicines and chemical reagents development and register, drug production, medicines and chemical reagents is managed, the link such as the drug management, management after appearing on the market adjusts a structure, the content that involves some vaccine government brings into vaccine management method.

Normative network sells drug action

The urgent need that accords with a condition medicaments whether add conditional approval, the behavior that how sells drug to the network undertakes superintendency... the heat problem that pays close attention to in the light of the public, edit draft made a response.

Some standing committee committee members, branch and social community put forward, ought to make clear medicines and chemical reagents to register the requirement of application, clinical to adding a condition to approve the imperative drug that treats severe disease makes a provision, allow medicines and chemical reagents to register certificate to make over, strengthen medicines and chemical reagents to produce the modificatory government in the process, normative network sells drug action.

To this, edit draft increased relevant provision:

The applicant ought to offer true, sufficient, reliable research data, data and sample, the security that proves drug, effectiveness and quality can charge a sex.

To according with conditional urgent need medicaments can add conditional approval.

Through approval, medicines and chemical reagents appears on the market permissive holder can make over medicines and chemical reagents to register certificate, suffer clearly let square condition and obligation.

The change in producing a course to medicines and chemical reagents executes classified management, major change ought to be examined and approve, other change ought to put on record or report, ought to evaluate in the round to changing the influence of item to undertake, test and verify.

The person that network of medicines and chemical reagents sells tripartite platform to offer ought to put on record, fulfill aptitude to examine, check and report illegal behavior, stop to offer a network to sell the obligation such as platform service, must not sell tripartite platform clearly to sell prescription drug directly through network of medicines and chemical reagents.

Strengthen medicines and chemical reagents of barrier of assure of medical price inspect to supply

How to solve tall problem of medical price theory, make a patient true experience material benefit?

Some standing committee comprise personnel, place and social community to put forward, drug price theory is mixed high the outstanding issue that supplying shortage is domain of medicines and chemical reagents, the proposal adopts measure to strengthen medical price to superintend, safeguard medicines and chemical reagents is supplied.

Be aimed at high issue of drug price theory, edit draft regulation, the country undertakes monitoring to drug price, begin cost price style to check when necessary, strengthen drug price to supervise an examination, investigate drug price to violate act lawfully, uphold drug price order.

Supply shortage problem in the light of medicines and chemical reagents, edit draft regulation, the country implements early-warning of shortage medicines and chemical reagents and system of detailed list management. The country encourages the development of shortage medicines and chemical reagents and production,

Concerned branch of the State Council can take the step such as interpose of proper production, price and constituent entrance to shortage medicines and chemical reagents, safeguard medicines and chemical reagents is supplied.

Medicines and chemical reagents appears on the market management company of production of permissive holder, drug ought to perform social duty, produce and supply what ensure medicines and chemical reagents.

The victim can advocate castigatory sex is compensated for

Some standing committee committee members, place and social community put forward, ought to increase the condemnatory strength that violates act to medicines and chemical reagents further, raise illegal cost, punish severely punish again, form awe.

To this, draft makes following modification:

The action that increases merit punishment is phyletic. Harmful to developing drug according to the regulation response is monitored or report, the drug that course of study of condition foreign enterprise establishs in Chinese churchyard appears on the market the legal entity that permissive holder perhaps appoints on behalf of the orgnaization did not fulfil relevant obligation lawfully, network of medicines and chemical reagents sells tripartite platform to did not fulfill aptitude to examine, report illegal behavior, stop to offer a network to sell security of the obligation such as platform service and dispersed and fictional, false medicines and chemical reagents information violates act 4 kinds, increase the legal liability with relevant provision.

Increase condemnatory strength. To having card production manages medicines and chemical reagents, production to sell drug of false medicine bad, disobey medicines and chemical reagents to produce quality management standard or medicines and chemical reagents manages quality management standard to wait for illegal behavior, raise amerce forehead to spend. Fulfil punishment to arrive person, direct and the legal representative of unit of drug of bad of false to be engaged in producing a sale medicine, main controller, responsible director staff and other responsibility personnel, increase to find out the regulation of criminal responsibility lawfully; To considering as what commit a crime or do not make crime lawfully, increase the provision that can give administration to detain.

Raise castigatory sex compensation. Producing false medicine, bad medicine to perhaps be known perfectly well is false medicine, bad medicine still sell, cause die or health damages badly, the victim can advocate corresponding castigatory sex is compensated for.

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