The World Health Organisation (WHO) declared the Global outbreak of Monkeypox as a Public Health Emergency of International Concern (PHEIC) on July 23, 2022. A week later, on July 29, 2022, Brazil recorded its first fatality (the first death caused by Monkeypox outside of Africa), according to Brazil’s Health Ministry.
- October 14, 2022 Pharmaceuticals, Regulatory Affairs
- October 13, 2022 Regulatory Affairs, Publishing & Submissions, Regulatory Software & Services
eCTD has turned into a standard norm for industry-wide submissions in a majority of regions across the globe. It provided a single standard for the electronic transmission of submissions data and enabled the industry to communicate and exchange information with Health Authorities harmoniously.
- October 13, 2022 Medical Devices, Regulatory Affairs
The Class I medical device manufacturers are now focusing on transitioning from European Medical Device Directives (MDD) to Medical Devices Regulation (EU MDR) 2017/745. For the CE certificates issued under MDD before the implementation of MDR to remain valid until May 2024, this is applicable only under certain conditions. The devices that are under Class I are required to be compliant with MDR.
- October 12, 2022 Medical Devices, Regulatory Affairs
The European Union Medical Devices Regulation (EU MDR) 2017/745 defines the scope of the sterile medical devices as devices that must be microorganism-free (bacteria, viruses, etc.). Class I devices with sterile function can also obtain a self-certification, but it differs in terms of requirements compared to other sub-categories of Class I devices.
- October 11, 2022 Medical Devices, Regulatory Affairs
Innovations in medical devices have increased manifold in recent years. This acceleration can be especially attributed to the vast development in cloud computing and the Internet of Things (IoT). Similarly, Software as a Medical Device (SaMD) has seen an increase in demand and remains a major contributor to the overall growth of the device industry.
- October 7, 2022 Regulatory Affairs, Regulatory Software & Services
In September 2022, the USFDA released a revised technical conformance guide for electronic Common Technical Document (eCTD) v4.0. The guide provides specifications, recommendations, and general considerations while submitting eCTD-based electronic submissions to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER).
- October 6, 2022 Pharmaceuticals, Regulatory Labeling
A Summary of Product Characteristics (SmPC) is an easy-to-access and product-specific resource enclosed with all the essential information about a product. The document includes the forms, clinical parameters, and pharmacological properties written and updated by organizations depending on their research and knowledge of a specific medicinal product.
- October 4, 2022 Pharmaceuticals, Regulatory Artwork Services
Artwork is a powerful branding tool in the pharmaceutical industry as it helps organizations create the correct brand perceptions.
- September 27, 2022 Pharmaceuticals, Publishing & Submissions
During the COVID-19 pandemic, Real-World Data (RWD) and Real-World Evidence (RWE) were essential sources of information for the United States Food and Drug Administration (USFDA) to expedite the approvals of COVID-19 vaccines and therapeutics and to allow other clinical studies to progress under the changing circumstances. For post-approval studies currently, the FDA ensures the appropriate RWD is utilized to create RWE.…
- September 26, 2022 Food and Food Supplements
The Food Safety and Standards Authority of India (FSSAI) released a Draft Notification on September 14, 2022, amending the Food Safety and Standards (Labeling & Display) Regulations, 2020. These regulations may be called the Food Safety and Standards (Labeling & Display) Amendment Regulations, 2022. It shall come into force on the date of their final publication in the Official Gazette.