Over the last 5 to 10 years, China has issued a number of anti-corruption regulations that have dealt with healthcare institutions and medical personnel. Corruption has been lowered but still exists. However, on October 11, the State Administration for Market Regulation issued... Read More
The Delhi High Court has passed landmark orders for the Indian government regarding rare disease treatment, focusing on funding, regulatory reforms, and price controls. The court has ordered the establishment of a National Fund for Rare Diseases (NFRD), with an initial allocation over... Read More
Amidst a number of negative healthcare trends in China including competitive locally made products that compete with the West, reduced drug and device reimbursement, the pending Biosecure Act, and increased political frictions, China has announced 2 new policies to help increase foreign healthcare... Read More
In an effort to improve the quality of medical devices distributed in Indonesia, the Indonesian MOH has put in place stricter guidelines. According to the new Circular Letter 03, starting on July 1, 2024, it will now be required that Indonesian medical... Read More
In October 2024, Singapore’s Health Sciences Authority (HSA) updated its Guidance on Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers. From October 1, 2024, evidence demonstrating GMP compliance is mandatory for all new or generic drug applications and minor variations... Read More
Japan has had a flurry of new drug regulations to ease their drug lag problem and make their country more conducive to innovative drugs. As mentioned last month, Japan’s PMDA is now allowing the submission of some innovative drug applications in English and will respond... Read More
In early September, India’s Department of Pharmaceuticals has requested that there is a new code set up for marketing and advertising medical devices in-country. The new regulation is titled – Uniform Code for Marketing Practices in Medical Devices (UCMPMD). Prior to this... Read More
Drug reviews in Korea take a lot longer than in other advanced global markets. The current MFDS review time is about 420 days, and the new plan is to reduce this to 295 days. To do this, the MFDS is going to... Read More
China’s National Medical Products Administration has issued a Pilot Work Program to fast-track innovative drug clinical trial approvals. According to the notice, the normal review period has been cut from 60 to 30 working days, and this change will be applied to... Read More
Device registration in Malaysia is aided by prior approval in the EU/US. An EC Certificate (EU CE Marking) or EC Declaration of Conformity is recognized by the Malaysia Medical Device Authority (MDA) as an approved type for the conformity assessment process for... Read More