India in January 2019 lifted price controls on medicines developed by foreign companies. The move, long anticipated, affects so-called orphan drugs that treat rare medical conditions and other groundbreaking drug therapies. The action exempts new drugs patented under the Indian Patent Act... Read More
Seeking to codify higher standards for the production, transportation and storage of vaccines, Chinese authorities in January drafted a draft Vaccine Administration Law that would tighten restrictions on vaccines. Under the draft law, companies, firms or non-profit organizations are subject to government... Read More
In an effort to bolster the confidentiality of submissions to its medical device review process, the Chinese government in January 2019 put in place a document registration system applicants may use while seeking approval for their products. The system being implemented by... Read More
Pushing to improve the quality of generic drugs available on the Indian market, the Central Drugs Standard Control Organisation (CDSCO) plans to require manufacturers to submit to tests proving their products are biologically equivalent to the corresponding patented drug. An implementation date... Read More
Moving to make complying with its emerging medical device regulations simpler, Hong Kong authorities have launched an online tool to help manufacturers of in vitro devices (IVDs) properly classify their products. The platform unveiled by Hong Kong’s Medical Device Control Office (MDCO),... Read More
Just two multinational pharmaceutical manufacturers have been selected to supply drugs to 11 major Chinese cities, as a government pilot program designed to glean lower drug prices in China goes into effect. The two firms, AstraZeneca and Bristol-Myers Squibb, will supply key... Read More
China’s National Medical Products Administration (NMPA) in December began publicly soliciting opinions on proposed revisions to 94 medical device industry standards. The revisions, part of a broad reworking of medical device industry standards in China over the past two years, are expected... Read More
In November 2018, Malaysia’s Medical Device Authority released the Third Edition of its Guidance Documents on Requirements for Medical Device Labeling. Major changes include: Medical devices for home use must be labeled in Bahasa Malaysia. Other types of medical devices shall be... Read More
More than 4,000 food and drug products have been approved for sale in the Philippines since November 2018, as authorities speed to clear backlogs in the permitting process built up over years of neglect. The move by the Food and Drug Administration... Read More
Addressing the rapid development of in-vitro diagnostics technologies and their increasing usefulness, China’s National Medical Products Administration (NMPA) in November refined its system of classifying in-vitro diagnostic (IVD) devices to better reflect the varying levels of risk they contain. Under the new... Read More