Consigned items duty to produce on the rise, Overregulation

Notice of submission of GMP evaluation data for all consignees through revision of rules

Concern about contracting consignment trades, 'triple distress' due to lower prices

As the MFDA foretells the resurgence of mandatory production of three batches of consignment items as a solution to the problem of generic stagnation, the pharmaceutical industry is pushing for excessive regulation.

 

It is dissatisfied that consignment production is bound to be stopped if mandatory production of consignment items is obligated while abolishing consignment.

 

The MFDA included these details when it announced legislation on the revision of some of the rules on safety of medicines and others.

 

In addition, it is necessary to submit data on the evaluation of the GMP implementation status in the future manufacturing process.

 

The GMP implementation assessment data also includes validation data to verify the uniformity of the product.

 

Validation data is pre-checked through three batch productions.

 

In other words, a drug produced at another plant will have to produce three batches of data from the plant when approved.

 

Depending on the manufacturing facilities, as many as 100,000 tablets are produced per batch.

 

When placed three times, 300,000 tablets are made.

 

Pharmaceutical companies will not lose money if they sell 300,000 tablets produced for permits.

 

In addition, submission of GMP data will also lengthen the license period.

 

This is a big burden for the consignment company.

 

Of course, trustees can benefit from additional production.

 

However, most pharmaceutical companies are expected to suffer damage in the midst of active consignment production.

 

In addition, the MFDA's stance is to phase out the allowance for joint and consigned living.

 

The MFDA announced in a regulation notice that, starting from next June, the number of items allowed for joint and entrusted livelihood will be limited to three companies, and not allowed from June 2023.

 

In addition, the MFDA is in a position to lower drug prices for consignment and joint livestock products.

 

In the meantime, if consigned drugs are reinstated to become mandatory to produce three batches, the counterfeiting transaction between pharmaceutical companies will be markedly reduced.

 

The provision of mandatory production data for three batches of consignment manufacturing items disappeared following the introduction of the 2014 GMP Conformity Decision.

 

The revival will bring back regulation in almost five years An official in the pharmaceutical industry said, "In the event of last year's Valsartan, there was an opinion that we would revive the production of three batches of consignment items without leaving the co-provisioning regulations." The MFDA announced the revision of the rules on safety, such as the drugs, as well as mandating the production of three batches of consigned drugs, and expanding the subjects for submitting biotest data to all specialty drugs, and eliminating the exemptions for submitting the law.

 

In addition, it will revise the report on overseas safety measures related to the suspension or withdrawal within from 15 days to 3 days, and the burden on pharmaceutical companies is expected to increase further.