After a prolonged duration of 18 years, IVD (In vitro Diagnostic) Medical Devices finally fall under the purview of Health Canada’s much awaited finalized labeling guidance. The first draft of this guidance was issued in the year 1998. This guidance emphasizes mainly on:
- May 10, 2016 Medical Devices, Regulatory Labeling, Health Authority Updates
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
- April 26, 2016 Medical Devices, Regulatory Affairs, Health Authority Updates
Heads-up: Class II Device’s Unique Device Identifier (UDI) Compliance is here. As part of the phased approach to UDIs, the US Food and Drug Authority (FDA) has mandated manufacturers of Class II devices to get complied by Sep 24 2016.
- April 21, 2016 Pharmaceuticals, Regulatory Labeling, Health Authority Updates
Medication errors are prevalent, perilous, and intricate. The stats associated with medication errors are alarming the need for control over this issue.
- April 19, 2016 Health Authority Updates
FDA releases new draft guidance on cGMP Drug Manufacturing
Regulatory functions such as submission and publishing, regulatory intelligence, labeling, etc. are intricate areas of the regulatory spectrum that are ever evolving. There is no doubt to the fact that some real time challenges are involved in submission processes especially now when the world is shifting from paper to electronic submissions.
Draw a finite line
Are you geared up with blocked timelines and strategies for upcoming drug / cosmetic Regulatory mandate? Before deciding on your next task, recheck on the category of your product to be marketed. Is it a drug or a cosmetic? Draw a finite line and understand corresponding Regulatory implications and laws to ensure your marketing efforts won’t go in vain.
- April 5, 2016 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
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.
- March 31, 2016 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
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. No new medicine registrations will be accepted in any format other than eCTD from 1st July, 2016 onwards.
- March 29, 2016 Medical Devices, Compliance, Audit and Validation, Health Authority Updates
Medical device’s global standard for quality management system gets a long-awaited amendment to a new standard: ISO 13485.