With an increase in self-medication, the demand to have drug labels provide as much information as possible is growing. In the pharmaceutical industry, customers and patients must be protected by a clear, concise label that provides information about medications. Drug labels must provide customers with a way to know more about their formulas, how they are used, and what to do if there is a medical emergency.
- July 29, 2022 Pharmaceuticals, Regulatory Labeling
- July 27, 2022 Pharmaceuticals, Regulatory Labeling
In 1999, the European Medicines Assessment Agency (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) set out to design a new system to share product information electronically to support the submission of new products or variations post-approval. This was called Product Information Management (PIM), which was withdrawn in 2011.
- July 27, 2022 Pharmaceuticals, Regulatory Labeling
To market medicinal products in the European Union (EU) countries, pharmaceutical companies must prepare and translate documents like the Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), and product labels in twenty-four (24) EMA-approved languages. A dedicated Working Party (WP) is assigned by the European Medicines Agency (EMA) for Quality Review of Documents (QRD).
- July 18, 2022 Pharmaceuticals, Regulatory Artwork Services
With serialization legislation introduced in two (02) major drug markets, namely, the USA and the EU, the pharma industry is being forced to take action on a large scale. On the other side, people are slowly realizing the benefits that serialization could bring in terms of patient safety and supply chain management. The mandates to serialize drugs are driven in large part by a need to secure supply chains.
- July 18, 2022 Pharmaceuticals, Regulatory Artwork Services, Regulatory Labeling
In-depth analyses will highlight how pharmaceutical packaging, labeling, serialization, tracking, and traceability enhance consumer safety and transparency in the supply chain, as well as benefit pharmaceutical packaging that go beyond compliance with laws.
- June 28, 2022 Regulatory Affairs, Regulatory Software & Services
Introducing innovative products across global marketplaces is imperative for life sciences companies to ensure profitability and maintain their presence in the market. Regulatory compliance and authorizations being the key factors behind any winning launch, inadequate Regulatory information can trigger an increase in costs and time-to-market.
- June 20, 2022 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions, Market Access
Most life sciences organizations find it difficult to streamline their Regulatory submissions process due to frequent changes in the submission guidelines. According to a recent analysis conducted by the United States Food and Drug Administration (USFDA), 32% of submissions with study data had critical data conformance issues.
- June 20, 2022 Pharmaceuticals, Regulatory Affairs
The prime goal of a Health Authority (HA) is to promote and protect the interests of those it serves by amending and introducing new regulations. The European Medicines Regulatory Network (EMRN) is a network of competent authorities that work in sync to draft guidance documents that regulate medicines while upholding the standard of the medicinal products being authorized.
- June 17, 2022 Medical Devices, Regulatory Affairs
With the vision of global device traceability, South Korea’s Ministry of Food and Drug Safety (MFDS) has suggested/mandated? a new Regulatory requirement, for incorporating Unique Device Identification system (UDI) on medical devices. Medical device registration and UDI are integrated procedures, and UDI is a prerequisite for establishing medical devices in the Korean market.
- June 17, 2022 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
The journey of a drug product doesn’t end with its post-market authorization. The drug’s performance is now openly evaluated by the general population. To safeguard the population against any undesirable outcomes, post the consumption of a drug, a pharmacovigilance alert system is in place.