Typical case of high-quality development of services in Inner Mongolia 1: Inner Mongolia’s first generic drug variety passed the consistency evaluation In recent years, the Inner Mongolia Autonomous Region Market Supervision and Administration Bureau has established the basic pri

Inner Mongolia launches services High-quality development Typical case 1: Inner Mongolia’s first generic drug variety passes consistency evaluation

In recent years, Inner Mongolia Autonomous Region Market Supervision and Administration Bureau has established the basic principle of being enterprise demand-oriented, and in various league cities A team of experts was organized to investigate the needs of the enterprises one by one among the enterprises that applied, and some enterprises were selected to carry out "point-to-point" research to accurately determine service projects for the enterprises.

Lantai Pharmaceutical Compound Licorice Tablets fully automated packaging production line

In April 2020, Isoniazid tablets (specification: 0.1g) produced by of Inner Mongolia Lantai Pharmaceutical Co., Ltd. passed the generic drug quality and efficacy consistency evaluation and obtained the State Food and Drug Administration approval document, this is the first variety in Inner Mongolia to apply for and pass the national generic drug consistency evaluation. The approval of this generic drug has achieved a "zero" breakthrough in the consistency evaluation of generic drugs in Inner Mongolia, and will play a leading and leading role in the implementation of generic drug consistency evaluation by pharmaceutical manufacturers in our region.

"In the past two years, in providing precise services to enterprises, the Inner Mongolia Autonomous Region Drug Control Research Institute has adopted a three-step approach of first investigating ' pulse diagnosis ', then 'prescribing' the symptoms, and then 'treating' the patients. Inner Mongolia Lantai Medicine With the precise help of our hospital, the isoniazid tablets produced by Inner Mongolia Lantai Pharmaceutical Co., Ltd. passed the quality and efficacy consistency evaluation of generic drugs. It was approved by the State Food and Drug Administration and became the first variety in the region to apply for and pass the national generic drug consistency evaluation," Zhou Gang, director of the Chemical Drug Laboratory of the Inner Mongolia Autonomous Region Drug Inspection Institute, said in an interview with reporters.

He told reporters that isoniazid tablets are first-line anti-tuberculosis drugs and can be used in combination with other anti-tuberculosis drugs to treat tuberculosis . By providing enterprises with multi-party guidance, precise services, and free technical support, they have gained a real sense of gain. It has also solved development bottlenecks for more and more enterprises, and has won recognition and recognition from the government and enterprises.

Inner Mongolia Drug Control Institute staff conducted on-site training

The reporter learned that there are 31 drug manufacturers in the Inner Mongolia Autonomous Region involved in the consistency evaluation of generic drugs, 1173 oral solid preparations and injections, and currently there are 16 varieties of 9 companies. , 22 document numbers are carrying out research work.

It is understood that the Inner Mongolia Autonomous Region attaches great importance to the consistency evaluation of the quality and efficacy of generic drugs, and has included them in the scope of support for the "three products" special action of the national consumer goods industry. The acceptance of applications or filing of clinical trials for generic drug consistency evaluation varieties is the node. , an initial subsidy of 300,000 yuan will be given, and individual varieties that pass the evaluation will be given a subsidy of up to 3 million yuan, and support will be provided in drug bidding and procurement and medical insurance payment.

In the next step, the Inner Mongolia Autonomous Region Market Supervision and Administration Bureau will adhere to demand-oriented, problem-oriented, and effect-oriented, strengthen coordination and linkage with relevant departments of the Inner Mongolia Autonomous Region, promote the reform of the review and approval system, encourage and support enterprise drug research and development innovation, strengthen service guidance, and make every effort to promote Generic drug consistency evaluation work promotes the high-quality development of the pharmaceutical industry in Inner Mongolia Autonomous Region. Text·Photography/Northern Newspaper Zhengbei.com reporter Liu Rui