CSO expenditure report Act, effective immediately

Designation of a drug day, punishment of buyers of specialized drugs, and expansion of central medicine; etc. are promulgated

The government promulgated the revised Pharmacist Act today (20th), which includes restrictions on co-living and clinical 1+3 of generic and new drugs and mandatory preparation of CSO expenditure reports.

 

In accordance with the revised Pharmaceutical Law, restrictions on 1+3 generic and improvement new drugs and regulations requiring CSOs to be included in the scope of pharmaceutical suppliers and to prepare expenditure reports will be enforced immediately after promulgation.

 

Dailypharm summarized the details and timing of implementation of the revised Pharmacist Act.

 

◆Limitation of 1+3 on generic and improvement new drugs ◆ The regulation shall be implemented immediately after the announcement to specify data to be submitted when marketing of generic and improvement new drugs.

 

New generics and improvements to obtain marketing permits after today will be subject to restrictions on clinical data.

 

However, the 1+3 regulation was not applied to medicines (IND), which are already undergoing clinical trials.

 

At this time, pharmaceutical companies approved for the clinical trial plan must submit and report to the Minister of Food and Drug Safety within one month from the enforcement date of the revised Pharmaceutical Law, along with evidence that they have decided to jointly develop medicine.

 

In addition, the government decided not to apply 1+3 regulations to the clinical trial data before the enforcement of the revised Pharmaceutical Law.

 

It does not apply regulation retrospectively.(Article 31 (10 through 15) The provisions that prohibit reauthorization and reporting of items less than five years after the date of cancellation of item permits or reports of changes by false or illegal means, and medicines less than three years after the cancellation.

 

(Article 31(16)) ◆Compulsory preparation and submission of CSO expenditure reports ◆ The provisions to include pharmaceutical companies and CSOs entrusted with drug sales promotion tasks to prevent MDs and pharmacists from providing economic benefits such as of January 21 next year.

 

The CSO's regulation requiring preparation and submission of medical and pharmacist expenditure reports and requiring related books and evidence data to be kept for five years will also take effect on January 21st next year.

 

In addition, regulations that allow the Minister of Health and Welfare to conduct a survey on the expenditure reports of pharmaceutical suppliers and announce the results and entrust the work to related institutions or organizations will take effect six months after the promulgation (January 21 next year.

 

The regulation on the disclosure of CSO expenditure reports to the public by an ordinance of the MOHW shall take effect two years after the promulgation, that is, July 21, 2023.(Article 47, Article 47-2, Article 69-4, and Article 95) ◆Designation of Drug Day as National Anniversary =A provision that designates November 18 every year as Drug Day and allows local governments to conduct events, education, and promotional projects or support related group activities shall be implemented immediately.

 

November 18 is expected to be the first day of Drug Day as a national holiday event.(Article 2) ◆Punishment of Rx drug buyers = Regulations that prohibit and punish steroid injections, ephedrine injections, and specialist drugs to consumers who cannot sell drugs such as medicine and pharmacists will also be enforced six months after the date of promulgation.

 

That is, it will take effect on January 21 next year.

 

If the regulation is enforced, consumers who illegally purchase Rx drugs will be fined up to 1 million won, and those who report illegal buyers will be able to pay rewards set by Presidential Decree.(Article 47-4 and 90 and Article 98 (1) 7-3) ◆Expanding the size of the Central Pharmaceutical Review Committee=The provision to increase the number of the Central Pharmaceutical Review Committee, an advisory body of the MOHW and the MFDS, from one to two.

 

◆Legalization of phase 3 conditional permission system = The provision to upgrade phase 3 conditional quick marketing permission to the Pharmacist Act, which is operated by the notice, shall take effect six months after its promulgation (January 21 next year).

 

It allows the head of the MFDS to quickly approve medicines for serious or rare diseases prescribed by the Act on the Management of Serious or Rare Diseases after a central medical review, and clarified procedures and submissions.

 

Pharmaceutical companies with conditional authorized medicines must check the implementation of the conditions and report them to the head of the MFDS, and the head of the MFDS is allowed to order the implementation of the conditions.

 

If pharmaceutical company that receives conditional permission for facilities and items by fraud or fraudulent means fails to report or fulfills an order to fulfill the conditions, the conditional permission can be revoked.

 

The Pharmaceutical Affairs Act has also raised the provisions related to pharmaceuticals that can be reviewed preferentially for other licensed medicines.(Articles 35 and 35-2 through 6)