Companies done submitting metformin record, what now?

Active ingredient and complete product manufacturing report submission was due Dec. 17

Ministry of Food and Drug Safety (MFDS)

Pharmaceutical companies in Korea have completed submitting usage record of metformin medicine to the government body.

 

The industry seems to be patiently waiting for the government’s follow-up action on finding impurity in metformin-containing drugs.

 

According to pharmaceutical industry insiders on Dec.

 

18, pharmaceutical companies have completed submission of metformin medicine manufacturing status report as requested by Ministry of Food and Drug Safety (MFDS).

 

They compiled data from respective manufacturing plant and sent in the material until Dec.

 

17.

 

On Dec.

 

13, MFDS has asked the companies to hand in manufacturing record of drug items containing ‘metformin hydrochloride’ and detailed research result of using the active ingredient by Dec.

 

17.

 

MFDS requested information on the total number of pharmaceutical products containing metformin, name and number of items with manufacturing record, and name and number of items without manufacturing record.

 

The information should cover all items distributed considering use-by date of complete products.

 

For example, when an items’ use-by date is three years, then the item’s entire manufacturing record after December 2016 should have been submitted.

 

The ministry has also called for a full report on active ingredients used in the metformin products.

 

It is collecting detailed information on DMF registration number and manufacturing plant of a complete product containing the ingredient under each serial number.

 

MFDS preemptively taking a detailed look into the records of active ingredient usage, in case impurity is found.

 

When a specific active pharmaceutical ingredient and complete product is discovered with an issue, the ministry plans to take a prompt and accurate action based on the collected information.

 

Molecular structure of metformin

Impurity risk in metformin first started from Singapore.

 

On Dec.

 

4, Singapore’s Health Sciences Authority (HSA) recalled three items out of 46 metformin containing drugs they investigated.

 

The result confirmed contamination of N-Nitrosodimethylamine (NDMA) has surpassed daily acceptable level.

 

The pharmaceutical industry is anxious that the Korean regulator is “considering on taking follow-up actions like sales ban when the active ingredient is found contaminated”.

 

In fact, before the government body took an action on ranitidine and nizatidine cases, the ministry had reviewed detailed information on complete product and the active ingredients.

 

The ministry held back on the action for ranitidine and nizatidine medicine, until the thorough review on complete products and the ingredients was completed.

 

The ministry may decide to ban sales on metformin medicine, if it confirms the same active ingredient recalled in Singapore has been imported to Korea.

 

In the case of valsartan, MFDS had immediately ordered a sales ban on drugs with the substance when Europe decided to recall the products.

 

Metformin-containing complete products recalled in Singapore have not been imported to Korea, yet.

 

But whether or not the recalled active ingredient has been imported yet has not been confirmed.

 

Reportedly, the Singaporean health regulator decided to recall the products based not on testing result of active pharmaceutical ingredient, but on complete products.

 

However, it is highly unlikely that the Korean regulator would take an action in just a few days as it has not collected samples of metformin ingredients and complete products for testing.

 

Both for ranitidine and nizatidine medicine, the regulator announced the follow-up measure after collecting samples of ingredients and complete products from different manufacturing dates, along with a thorough review on usage record.

 

Ironically, the ministry has not presented an official procedure of NDMA testing for metformin, yet.

 

MFDS is currently working on NDMA testing for metformin, which is scheduled to be completed by the end of the year.

 

When the official testing procedure is set, the ministry is to collect the active ingredient and complete products for testing.