Pharma Mirror
NOVEMBER 7, 2023
Navigating regulatory compliance in the pharmaceutical industry is crucial to ensure the safety, efficacy, and quality of pharmaceutical products. The pharmaceutical industry is heavily regulated in most countries to protect public health and to maintain the integrity of the products.
Pharma in Brief
DECEMBER 3, 2023
This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.
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pharmaphorum
OCTOBER 12, 2022
Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data.
Pharma in Brief
APRIL 25, 2021
These amendments permit patents claiming different forms of a medicinal ingredient (e.g., different salt forms) of the medicinal ingredient in comparison to the Canadian Reference Product (“ CRP ”). Proposed PM(NOC) Amendments Restore Balance by Expanding PM(NOC) Regulation Protections.
Cloudbyz
JUNE 16, 2023
Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Purpose of Clinical Trial Data Archiving: Compliance: Regulatory authorities require clinical trial data to be retained for a specific duration to demonstrate compliance with guidelines and regulations.
Cloudbyz
APRIL 25, 2023
This comprehensive guide delves into the essentials of pharmacovigilance regulatory reporting, highlighting its significance in maintaining drug and device safety, and ensuring compliance with regulatory requirements. Different types of reports have specific timelines for submission, and delays may result in regulatory actions or penalties.
pharmaphorum
JULY 21, 2022
The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. On top of this, some regulations have changed, plunging more facilities into the possibility of not complying. Doing so means that businesses can check their compliance before an FDA inspection.
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