There are various Economic Operators (EOs) who play a vital role in a device supply chain while delivering them to the point of use. Given the importance of each role, the Swiss Medical Device Ordinance (MedDO; SR 812.213) has set out the roles and responsibilities for each of these EOs.
- February 21, 2022 Medical Devices
- February 18, 2022 Pharmaceuticals, Regulatory Affairs
A warning letter is an official message/letter issued from a health authority to an organization that violates the set rules and regulations. When it relates to pharmaceutical companies, they need to follow several Good Manufacturing Practices (GMPs), GCPs, GDPs, etc., to avoid such warnings. There are several instances in which any Health Authority (HA), particularly FDA, issues these letters.
- February 18, 2022 Pharmaceuticals
To note, there are many gaps in the Regulatory science that need to be addressed for the development and evaluation of medicine. Global Regulatory Agencies make strong efforts to close these gaps and enable access to innovative medicines that address the patient’s needs.
- February 17, 2022 Pharmaceuticals, Market Access
Based on the European Commission’s (EC) proposal on facilitating the movement of goods from Great Britain to Northern Ireland in October 2021, the Commission has now set up plans to maintain the medicines’ supply in specific markets post-Brexit.
- February 17, 2022 Pharmaceuticals, Health Authority Updates
Following the guidance in September 2020 on mitigating the risk of nitrosamine impurities in drug products, the United States Food and Drug Administration (USFDA) has recently suggested alternate approaches to reduce the formation of nitrosamine in certain products. According to the latest update, some methods can be incorporated by manufacturers for the prevention of such contaminations.
- February 16, 2022 Food and Food Supplements, Regulatory Affairs
On December 14, 2016, Health Canada published revisions to nutrition labeling, food color requirements, and the list of ingredients of the Food and Drug Regulations. The revisions intended to help Canadians easily understand the nutritional facts and list of ingredients to make informed choices. The major revisions include the following:
- February 16, 2022 Food and Food Supplements, Regulatory Affairs
The Food Safety and Standards Association of India (FSSAI) has recently announced new Regulations to amend the existing Food Safety and Standards (Import) Regulations, 2017. The Regulations came into force on November 06, 2021, and all the Food Business Operators (FBOs) must comply with all the Regulations from June 01, 2022.
- February 14, 2022 Medical Devices
With technological advancements, the adoption of wireless medical devices for patients and healthcare management is growing at a fast pace. It is anticipated that four (04) out of ten (10) medical devices installation will be wireless or portable by 2031, and the wireless portable medical device market is expected to reach USD 33 billion.
- February 4, 2022 Pharmaceuticals, Regulatory Affairs
A new report from a European generics trade association says that extreme cost-containment policies can adversely affect the generics supply chain vide consolidation of generics drug production and withdrawal of such products from the market.
- February 3, 2022 Biologicals, Pharmaceuticals
Over time, there have been huge developments in medicines and biologics sectors, and so have the changes in their respective Regulatory regimes and manufacturers’ responsibilities. On similar lines, recently, the TGA issued guidance describing the responsibilities of manufacturers of medicines and biologics. It is a step-by-step guide for: