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Are you planning for clinical or non-clinical studies post December 17, 2016? If yes, we suggest you take a look at Food and Drug Administration’s (FDA’s) study Data standards applicable for certain types of submissions to CDER and CBER.
In the October released guidance, Medicines Control Council (MCC) has given clarity for manufacturers who are willing to submit applications for medicine registrations in electronic common technical document (eCTD) format. The guidance mainly emphasized the implementation timelines o
When it comes to dossier submissions for medicine registrations, each country has its own Regulatory data requirements which should be submitted in set formats and templates. Likewise, dossier submissions towards South African market has specific format to be considered.
Ever evolving Regulatory landscape, healthcare system reforms, and on-going technological advancements: with these factors influencing regulatory procedures at the most, the biggest task for life sciences organizations is to reduce the operational costs while managing the procedural efficiency for end-to-end compliance.
Do you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017.
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
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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