[Reporter’s View]Recall the purpose of regulating biologics

Regulations on biological products were not prepared to punish its manufacturers

The Ministry of Food and Drug Safety visited 3 pharmaceutical distributors on the 21st to prepare a new guideline that reflects voices in the field and the realistic difficulties of the industry in preparing to comply with regulations on the distribution of biological products.

 

The government is resetting the guideline after the revised version of the ‘regulation on the Manufacture and Sales Management of Biological Products’ was implemented in January last year faced with strong opposition from the pharmaceutical distribution industry on the sudden rise in the distribution standards of biological products without considering the cost or preparation period.

 

The raised standards increased the cost of transporting biologicals that already have low distribution fees to the extent that many companies decided rather not to distribute them.

 

Also, the industry pointed out the difficulties in managing the temperature of biological products that have to be frequently shipped in small amounts to pharmacies like insulin.

 

Under the revised regulations, it is necessary to maintain 2-8 degrees at all times using transport containers equipped with automatic temperature recording devices when delivering biological products, and the record must be kept for two years.

 

Unlike the regulations that forbid even a single deviation from the designated temperature, there are times when the temperature may suddenly jump out of the reference range for unknown reasons in reality.

 

Although this has no effect on the efficacy of the drug because the temperature does not deviate for a long period of time, they are subject to punishment under the regulations.

 

This is why the distributors are struggling with the issue.

 

A representative of a company has been testing various transportation containers every day, including custom-made containers, but has not been able to find a solution even now.

 

It also depends on which and how many refrigerants are added.

 

This is why the industry is making complaints and requesting that the MFDS should suggest the type and number of refrigerants and containers used that are not too heavy, not too expensive, and have good temperature control for 24 hours.

 

This is the result of overlooking the fact that it takes a lot of money and a long preparation period to prepare a perfect cold chain.

 

More than 90% of pharmaceutical distributors are small and medium-sized enterprises (SMEs) that cannot afford to spend a lot of money on the cold chain of biologics.

 

However, the government implemented the revised regulations in just 6 months since it was announced, in a hurry to implement the regulations within the year.

 

Faced with backlash from the industry, the authorities granted a 6-month guidance period, but the end of the guidance period is now less than three months away.

 

The MFDS said it will include the details in the guidelines, but the problem is time.

 

If the companies do not abide by the regulations, they will be subject to punishments starting on July 17th.

 

There is not enough time for the authorities to rewrite and announce the guidelines and for the companies to complete preparations accordingly.

 

The original purpose of strengthening the regulations for the transport of biological products was to enable the safe delivery of drugs that are directly related to the people's right to health.

 

However, such hasty measures that are focused on administrative procedures and written deadlines leave much room for issues in the regulations that were made with good intentions.

 

This is why the government should show patience and take the right steps step by step so as not to defeat the purpose of strengthening the regulations.