GOV·Pharma starts work to localize 57 essential medicines

that are in need of self-sufficiency in Korea

21 finished drugs and 35 APIs that depend on imports due to low profitability

Korea Orphan & Essential Drug Center to finalize list after discussion with Ministry of Food and Drug Safety and Korea Pharmaceutical and Bio-Pharma Manufacturers Association...” will additionally collect industry opinion”

The government and the pharmaceutical industry have entered the final stages of localizing the finished drug products and active pharmaceutical ingredients that are essential for national disease control and prevention as well as the treatment of emergency patients.

 

The supply of such products and ingredients has been mainly dependent on imports despite the evident need to be manufactured and produced in Korea due to low profitability.

 

Among drugs that are imported from 3 or fewer countries and therefore are vulnerable supply-wise, those from highly export-dependent countries of China, Japan, and India will be finally confirmed, upon which the government and the pharmaceutical industry plan to cooperate in securing domestic production technologies.

 

The movement bears significance as it is the first time the government and the pharmaceutical industry joined forces to fundamentally increase the self-sufficiency rate of rare or essential drugs that are subject to stable supply measures in Korea.

 

On the 12th, the Korea Orphan & Essential Drug Center (KODC) announced that it has tentatively finalized the list of 21 finished drugs and 35 APIs that are deemed to be in need of domestic technology development after discussion with the Ministry of Food and Drug Safety (MFDS) and Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), and will be collecting opinions from the industry as its last step.

 

After collecting and reviewing opinions submitted by pharmaceutical companies, the KODC will hold an expert advisory meeting and finalize the list.

 

Indications for the 21 tentatively confirmed finished drugs that were chosen due to the diseases’ difficulty in treatment or rarity of their patient group were treatments for emergency hypertension, ulcerative colitis, multiple myeloma, phosphorus excretion, acute heart failure or bradycardia, iron deficiency in patients unable to take oral medications, parasitic infection, adrenogenital syndrome, malignant hyperthermia, iron intoxication, methanol intoxication, Dravet syndrome, etc.

 

Subject products were: Nitroprusside injection, mesalamine suppository·powder, melphalan tablet, bromocriptine oral tablet, sevelamer powder, etomidate injection, amiodarone injection, imiquimod cream, isoproterenol injection, ferric carboxymaltose hydroxide Injections, clarithromycin injections, pentamidine injections, fludrocortisone tablets, nisoldipine tablets, amiodarone hydrochloride tablets, dantrolene sodium injections, deferoxamine injections, dehydrated ethanol injections, stiripentol capsules, anakinra injections, etc.

 

The 36 active pharmaceutical ingredients that were imported from countries with high import-dependency such as China, India, and Japan, are used for Brucellosis tularemia plague, Wilms' tumor, anthrax·plague·tularemia, drug-induced dystonia, Parkinson's disease, acute and chronic diarrhea, hypothyroidism, invasive fungal infection, supraventricular tachycardia, sepsis, tuberculosis, patent ductus arteriosus in preterm infants, Cushing's syndrome, atrophic vaginitis kraurosis vulvae, etc., that pose a fatal threat due to terrorism risk or in disease control and prevention in the nation, or have a rare patient group.

 

The subject ingredients are Levodopa/benserazide tablet, loperamide capsule, liothyronine tablet, lincomycin hydrochloride capsule, voriconazole injection, bisoprolol tablet, salbutamol inhalent, adenosine injection, amiodarone tablet, amikacin injection, Amphotericin B injection, edaravone injection, ethambutol tablet, captopril tablet, clindamycin injection·capsule, pyridoxine injection, albendazole tablet, ketoconazole tablet, etc.

 

The KODC plans to finalize the selection of drugs in need of stable supply after holding an expert advisory meeting on their selection criteria and considering their individual need for development, etc.

 

In addition, in consideration of the potential for domestic development, industry interest, and the international supply network status of drugs that are not on the candidate list, the KODC will be collecting opinions on finished drugs and APIS that the industry believes are in need of domestic manufacturing technologies.

 

A KODC official said, “We ask pharmaceutical companies that have separate opinions on our drug list selection, such as addition or deletion of items or the need for priority development, to submit their reviewed opinions and reasons.

 

We will also be identifying pharmaceutical companies that are willing to produce products that are not yet approved for the manufacture of finished pharmaceuticals on paper, such as APIs in the Drug Master File system that are only being imported in Korea.”.

 

Meanwhile, KODC is in charge of the MFDS’s research project on establishing a stable supply system for products with concerns over unstable supply and demand, focusing on National essential medicines that are used in public health crises.