Saturday , February 27 2021

[약업신문]Restrictions on Medicines and Bi … 7 Regulations



Exemption from Prescription Drug Prescription for Drug Injection Registration – Improvement of General Drug Approval Scam

The Korea Manufacturers' Association said seven of the recommendations made by the pharmaceutical and biotechnology organizations were included in improving regulation on "innovation of regulatory reforms in the new industry" published by the Ministry of State Planning on January 15.

First, some injection materials such as glucose solution are exempt from the duty to prescribe the drug. In the case of all injections applicable to the approval of a new product, the registered pharmaceutical substance should be used but there is not enough registered drug and it is difficult to develop a new drug for injecting distillation. Therefore, in order to promote the research and development of injectable drugs, we have decided not to include injectable drugs such as physiological saline solution, glucose solution, and injection of a dietary supplement from all the "injectable substances" that are the subject of the pharmaceutical prescription.

In the case of imported generic drugs, the exemption for safety and efficacy was exempt only in cases where these drugs were imported to foreign drug stores, but the amendment program should change the general screening system for approval of the drug by modifying related messages.

In addition, information on the distribution of the drug subject to recovery is provided to the pharmaceutical companies that are required to collect the drug. As pharmaceutical manufacturers and importers need to recover drugs due to safety and efficacy issues, the exact question and delivery status of the drugs have not been identified and the collection has been compromised. Accordingly, information on distribution containing the final location of the drug to be withdrawn (location information as of the date of the collection instruction), etc., is submitted to the Registrar.

However, it only announced preliminary test results in case of approval or declaration of the drugs, however details of the dispute between the applicant and the department were not included in the notice. Reflecting on this reality, official discussions are discussed and agreed at the Food and Drug Administration's preliminary Food and Drug Safety Assessment meetings.

Regulatory innovations include those not included in the use of drug-related drugs when their use is increased due to unsold drugs or unstable supply and demand.

In addition, there is concern that the negative perception of the patient may expand, and therefore it is planned to simplify the approval of the gene therapy products approved through the online system.

In addition, if the original pharmaceutical companies do not follow the postmarket investigation, the first generic drug companies are allowed to investigate without exclusive sales, in the case of the first generic drugs, and others to cooperate. It was put into operation at the end of 2012.

Referring to the improvement in regulation, the association said: "This is a very desirable case of cooperation between the private sector and the government, because the industry's voices are reflected actively and the system is improved."


Source link