- Opinion
- [Reporter's view] Only 2% of patients
- by Eo, Yun-Ho Jun 23, 2022 05:50am
- Will the new EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer treatment, which was useless for existing TKI, be able to receive insurance benefits? It's all the same cancer, but it's different. Cancer species such as liver cancer, stomach cancer, and lung cancer, which we call, are only a simple category, and in fact, they are class
- Opinion
- [Reporter's view]Will arbitrary manufacturing be eradicated?
- by Kim, Jin-Gu Jun 8, 2022 05:56am
- A revision to the Pharmaceutical Affairs Act, which allows the imposition of "punitive fines" on pharmaceutical companies that violate GMPs, passed the National Assembly. It also included canceling the judgment of suitability for the GMP if a violation is found, and allowing a prison term of up to five years or a fine of up to 50 million won,
- Opinion
- [Reporter’s View] Differing indication and reimb standards
- by Eo, Yun-Ho Jun 2, 2022 05:58am
- There are some cases where the insurance reimbursement standards and the indication for a drug differs. This gap emerges as not all the uses of a drug approved by the regulatory authorities may be deemed appropriate by the insurance authorities to spend their limited insurance finances on. This is why voices of complaint often arise in
- Opinion
- [Reporter’s view] What was gained and lost with COVID R&D
- by Kim, Jin-Gu May 25, 2022 05:47am
- Literally, the companies have played it out to the end. By the companies, this reporter is referring to the developers of COVID-19 treatments and vaccines. Just 2 years ago, the developers had received the investors’ utmost interest. Stock prices soared when news broke out that a company is developing COVID-19 treatments or vaccines. The
- Opinion
- The Minister should be appointed to lead policy continuity
- by Lee, Hye-Kyung May 20, 2022 06:11am
- On the 13th, the Yoon Seok-yeol government announced the appointment of vice ministers, ministries, and commissioners. However, as the head of the Ministry of Food and Drug Safety was excluded from the list of appointments, many talks were exchanged about the background. The most credible argument was that the appointment of the head of th
- Opinion
- [Reporter’s View] New govnt signals expanded PE exemptions
- by Eo, Yun-Ho May 18, 2022 05:52am
- The inauguration of a new government brings hope and anticipation to each and every industry. The same goes for multinational pharmaceutical companies. In the pharmaceutical industry, hopes are rising for the expanded eligibility of the pharmacoeconomic evaluation exemption scheme. Although many agendas remain in need of resolution, suc
- Opinion
- [Reporter’s View] Now is the time for drug reclassification
- by Lee, Tak-Sun May 6, 2022 05:46am
- 10 years have already passed since the heated discussion arose on the drug reclassification and sale of over-the-counter drugs in non-pharmacy venues. As the Korean saying goes, even nature can change in one decade. In that not-so-long but also an epoch of a period in terms of change, many drugs have established safety profiles and await bet
- Opinion
- [Reporter’s View] Use of maintenance and adjuvant therapies
- by Eo, Yun-Ho May 4, 2022 06:03am
- Continuous administration of a drug for ‘prevention.' This is not a new concept. Patients have been taking drugs to ‘manage’ their chronic condition for a long time, and drugs such as anticoagulants exist for the purpose of prevention. This only became an issue after the concept of maintenance and adjuvant therapies were introduced
- Opinion
- [Reporter’s View]Recall the purpose of regulating biologics
- by Apr 27, 2022 06:04am
- 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 v
- Opinion
- [Reporter’s View] 1st oral abortion pill approval difficult
- by Lee, Hye-Kyung Apr 21, 2022 06:03am
- A year has passed since the decriminalization of the abortion ban has taken effect. The Korean Health and Medical Workers’ Union distributed a press release on the 11th on ‘ensuring safe abortion of the people 1 year after the decriminalization of abortion in Korea.’ The press release contained the request for marketing authorization o
