The idea of electronic regulatory submissions for pharmaceuticals predates the eCTD tool itself. In the late 1980s, initiatives such as CANDA (Computer-Aided New Drug Application) were explored by the US FDA (Food and Drug Administration) and European agencies. These early efforts sought to enhance efficiency and data access for reviewers.
In the Pharmaceutical Industry, Regulatory Documents are meticulously checked and consulted for the sake of public health care. Due to the sensitive nature of the data in such documents, managing and maintaining them in accordance with current compliance standards and laws is crucial; failure to do so incurs not just economic loss but also costs brand image and product launch delays. While regulatory documents today are in digital format, a centralized regulatory document management system can increase productivity and fasten compliance proceedings.
The life science industry plays a significant role in maintaining public health and medical emergencies which is why there are thorough checks on it and strict compliances to follow. Regulatory compliances in the life science industry must be followed to the letter, a mistake on any part will lead to delayed and ineffective medicines.
Electronic Common Technical Document (eCTD) submissions are a cornerstone in the life sciences industry, enabling streamlined and efficient regulatory processes. This is the reason companies globally have mandated the use of eCTD. However, the creation and submission of eCTDs come with their own set of challenges. In this comprehensive guide, we will explore these challenges and how regulatory software can help overcome them, ensuring compliance and maximizing return on investment (ROI).
Over the years, international organizations and the pharmaceutical industry have observed the detrimental effects it has on the environment. During all stages of their life cycle, medical products interact with the environment, but the production stage is where most effects take place.
Pharmaceutical products are released in the environment through intricate web of pathways which makes this issue multifaceted; pinpointing one direct or singular source is not possible. There three ways in which products are released into the environment
The world of pharmaceutical regulations is about to get a major upgrade with the implementation of eCTD 4.0. This standardized format promises a smoother journey for new drug applications submitted to regulatory bodies. But for companies eyeing a slice of the $141.5 billion Japanese pharmaceutical market, there's a crucial twist – Japan is accelerating the adoption timeline!
Below is an analysis of these highlights:
Ever wondered about the drug labels and what goes into creating the content for it? Of course it serves the purpose of providing information about the ingredients, usage and what the medication is used for but how do health authorities standardize the content structure for it? The answer is SPL (Structured Product Labelling) and SPM (Structured Product Monograph). While the two names might sound similar, they serve different purposes in the world of medicine.
The regulatory landscape is changing. It is no longer just a static document describing what compliance is. Today, with an ever-increasing demand for regulators, vast amounts of data are to be collected and analyzed to ensure compliance. This sets up a unique problem: handling this "big data" effectively while maintaining robust regulatory document management.
Over the past few years there has been a gradual increase in medical devices and technologies, consisting of sensitive data of high monetary and intelligence value along with patient/institution information. To avoid loss and destruction of intellectual property, cybersecurity in the pharmaceutical industry is crucial and non-negotiable.
Cybersecurity threats faced by pharmaceutical companies:
Governance on paper is designed around time and is continually evolving. New laws are born, standards evolve, and aligning with the ever-changing landscape gives the feeling of not catching up. However, an opposite situation is possible – foreseeing these changes; acting rather than waiting for the same to unfold; making you one step ahead of all your competitors.