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Japan has a unique set of processes and agencies for the regulation of drugs. The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are the two main Regulatory Agencies that oversee the approvals of the drugs as per the regulatory prerequisites in Japan.
Investigational New Drug (IND) Filing Process
Are you currently submitting eCTDs (electronic common technical documents) to European Region (EU)? Or planning for the same in near future? Then we suggest it’s time to pull up your socks as the EU is taking its turn in 2016.
With an announcement made on 3rd March, 2016 by the UAE Ministry of Health & Prevention, UAE becomes the second nation to implement eCTD in the MNEA region. All the pharmaceutical and health service provider companies are asked to follow eCTD structure and format of submission for new registrations of medicines.
From 13 June, 2016 onwards
Enabling Multi-region submissions, effortlessly
Decode the Health Canada, and US FDA new DMF Submission Mandates
Are you a DMF holder willing to submit your paper Drug Master Files (DMFs) to Health Canada? Or are you looking for a paper DMF submission partner?
FDA published a guidance in May 2015 announcing a deadline for electronic submission of active DMFs. As per these guidelines, DMF holders are required to submit the baseline submission that generally includes the Module 1, 2 and 3 of the present submissions. This submission should also take account of the most recent paper submissions if any.
In the last two decades, Thailand, a country with a population of approx. 67 million has witnessed a commendable growth in healthcare sector. After Indonesia, Thailand has the largest drug market that is expected to get double by the year 2020. As per research reports, the Thai government spends 14% on healthcare, which is more than many European countries.
The pharma industry operates in a dynamic and ever changing global environment governed by new regulations and mandates introduced by the Health Authorities. To get compliant with these mandates, companies are required to submit relevant information about their products to health authorities.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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