IND: The KFDA requires the following material for filing IND. Protocol: The protocol has to be fully translated into Korean. IB: Its summary has to be translated into Korean. Specification and analysis method: Submitted using the KFDA template in Korean. The original version has to be attached.
Introductory statement &general investigational plan: Its summary has to be translated into Korea.
Chemistry, manufacturing, and control information(CMC) / Biological Characteristics: Submitted using the KFDA template --in Korea. The original version has to be attached.
Pharmacology (Efficacy, General Pharmacological Effects): Its summary has to be translated into Korean.
Pharmacokinetics &Pharmacodynamics ( ADME): Its summary has to be translated into Korean.
Toxicology information: Its summary has to be translated into Korean.
Clinical Trials Results
References
The KFDA is to answer the IND application in 30 working days. The KFDA almost always requests supplement materials. It is safe to assume that the IND application will take 90 to 120 working days from filing the IND.
There is no need to have Korean partners in filing INDs, But only Korean entities can apply for the IND.
IRB: There is no national IRB. Each medical center runs its own IRB, meeting in general once a month. The protocol, IB, and CRF are generally required. The IRB submission is independent of the IND application.
Import permit: The IND is the import permit for investigational products. It takes less than a day to clear the custom.
Good Storage Practice: There are a number of companies with the IP storage space meeting the GSP requirement. They are generally drug importers or wholesalers. They will deliver the IP to study sites upon request. The charge is reasonable.
Drug labeling: Although not required, a Korean label is recommended. LSK can prepare Korean labels, and labels are attached when packaged.
Insurance: Injuries from the trial may be indemnified under a global coverage or a local coverage or both.
Investigators: Investigators are well trained, and are conversant in English. Most have spent some time in the US medical centers. Investigators are tightly woven together. In general, one committed investigator persuades other investigators into participating in clinical trials. It is an effective practice to recruit one investigator and use his/her network of investigators to add more investigators..
Patient recruitment: Each investigator has his/her own pool of patients, and clinical trial participants are recruited from the pool rather than by referral.
Medical centers: Medical centers must pass the KFDA inspection to participate in phase II and III clinical trials. Only a handful of medical centers have the facility and government permit for phase I.
Please forward any further questions to information@lskglobal.com .
Protocol: The protocol has to be fully translated into Korean.
