- Opinion
- [Reporter’s View]Year of regulations, principle vs practice
- by Kim, Jin-Gu Jan 5, 2022 05:57am
- As in every other year, regulations imposed on the pharmaceutical and biopharmaceutical industry are again expected to be further reinforced this year. In particular, GMP-related regulations will be strengthened even further. Starting this month, the government may impose punitive fines on the arbitrary manufacture of pharmaceuticals by c
- Opinion
- [Reporter’s View] Have we secured enough COVID-19 pills?
- by Dec 20, 2021 06:12am
- The world is in preparations to use oral COVID-19 treatments to end the pandemic. Following the UK, Demark became the second country to authorize the use of MSD’s (US Merck’s) ‘molnupiravir,’ with the EU and the US also reviewing approval of the said drug. Pfizer’s oral treatment ‘Paxlovid’ is also under regulatory review. Korea h
- Opinion
- [Reporter’s View] Moderna needs to learn the Korean way
- by Dec 14, 2021 05:57am
- “We expect the establishment of the Korean subsidiary will aid the smooth supply of mRNA vaccines and allow for a more active engagement and communication with the Korean government, media, and academia.” This was what Moderna had said on the 2nd to the invited media at a press conference. Moderna’s establishment of the Korean subsidia
- Opinion
- [Reporter's view] Despite ↑reimbursed drugs for rare dz
- by Eo, Yun-Ho Dec 10, 2021 05:52am
- The need for improvement emerges every year, but patients with rare diseases are still struggling. In particular, even if there are drugs, the number of patients is so small that it is difficult to prove the cost effectiveness and predict financial consumption, making it difficult to register insurance benefits. There were many opinions this
- Opinion
- [Reporter's view] Improving guidelines excluding PVA
- by Lee, Hye-Kyung Dec 9, 2021 05:58am
- The NHIS announced the revision of Article 6 (1) and (2) of the Price-Volume Agreement (PVA) detailed operation guidelines for "Article 6 (Drugs Excluding Negotiations)." According to the policy, The NHIS guidelines will be implemented immediately after the revision is made, but this time, they will be applied from January 1 next year after i
- Opinion
- [Reporter’s View] On the best way to issue impurity recalls
- by Lee, Tak-Sun Nov 29, 2021 05:58am
- Once again, impurities were detected in the losartan ingredient of antihypertensive drugs that are being used by many patients. Some pharmaceutical companies have already started product recalls under orders from the Ministry of Food and Safety. With the results of the companies’ impurity investigations being released one after another,
- Opinion
- [Reporter’s View] On HIRA's price cuts for PE waiver drugs
- by Eo, Yun-Ho Nov 15, 2021 05:56am
- HIRA’s unilateral notice of its decision leaves a lingering question on whether this really was the best way to conclude the discussions. Couldn't the government have included its favorite words - "in discussion" or "in coordination" - that it uses best? The Health Insurance Review and Assessment Service responded that the criteria for e
- Opinion
- [Reporter’s View] Verify the oral COVID-19 treatments
- by Lee, Tak-Sun Nov 10, 2021 05:55am
- Following COVID-19 vaccines, oral COVID-19 treatments are also expected to enter the market soon as the government plans to phase in 404,000 courses of COVID-19 oral antivirals from next February. If oral treatments for COVID-19 are introduced, Korea will have laid the groundwork for managing the COVID-19 virus like influenza. Also, c
- Opinion
- [Reporter’s View] New drugs for Alzheimer’s in development
- by Nov 5, 2021 05:24am
- "I felt like it was all a dream. But I wasn't sure if I was young dreaming that I’m older, or I was old dreaming that I was younger. I have Alzheimer's." This is what Hye-Ja Kim, acting as a dementia patient in the “The Light in Your Eyes” TV drama two years ago, said as she revealed her condition to her friends. The drama gained much a
- Opinion
- [Desk's view] It should also prepare for "With Corona"
- by Chon, Seung-Hyun Oct 25, 2021 05:50am
- The government has announced that it will shift the COVID-19 quarantine system to a "step-by-step daily recovery" (with COVID-19) centered on the management of the number of critically ill patients or deaths. As the proportion of COVID-19 vaccination completion exceeds 70%, a relaxed quarantine system such as lifting restrictions on operating
