Friday , June 18 2021

[약업신문]Pharmaceuticals and Bio Controls … 7 Restrictions



Avoidance of drugs for post insulating drugs registration – improvement of normal medication approval

The Korean Pharmaceutical Manufacturers Association said in a statement on January 15 that seven Planning and Biotech Associations of Pharmaceutical and Biotechnological Associations have regulated control over the achievement of "Regulatory Reform Innovation of the New Industry" announced by the State Planning Office on January 15.

First, some injections, like glucose solution, are excluded from the liability for registering the drug registry. In the case of all injections applicable to the new product approval, the use of registered drugs, but there was not enough drug product and difficulty developing new injections. To promote research and development of injection drugs, the physiological saline, glucose solution, & # 39; dirt attributes & # 39; We decided to avoid drugs that could stimulate nutrition, which is the issue of raw drug registration.

The amendment project needs to be modified to review the General Drug Licensing Examination System in case of safety and efficacy in cases of drugs imported into the drugs imported into foreign drugs. It's scheduled.

In addition, it provides information on the supply of drugs for drugs necessary to collect drugs. Drug manufacturers and importers are required to restore drugs due to the safety and efficacy of drugs. The scrutiny and distribution status of the drugs has not yet been identified, the collection is interrupted. Accordingly, the registrants also include distribution information that contains the last retention of the drug's withdrawal (location as the date of collection instruction).

However, the results of the initial test of approval or declaration of drugs have been issued, but the details of the dispute between the applicant and the department are not included in the notes. This reality reflects a formal minute discussion and debate at the primary review meetings of the Food and Drug Safety Evaluation Center of Korean Food and Drug Administration.

Regulatory innovation includes increasing use of drugs or drugs or drugs that are not necessarily due to unstable supply and demand.

Furthermore, there is anxiety to increase the patient's negative perceptions, so it has been designed to simplify the recognition of gene therapy products that are recognized by the online system.

Also, if the drug companies do not follow post-marketing inquiries, first-line generic drug companies should be investigated exclusively, and the first generic drugs and co-investigation of others. It took place by the end of 2012.

Regarding the improvement of the regulation, the Association declared, "This is a great opportunity between the private sector and the government, because the sound of industry is actively reflected and the actual system is improved."


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