- What We Do
- Resources
- News & Events
- About
- Contact
Please Wait...
The Indian Pharmacopeia Commission recently published a Pharmacovigilance Guidance Document for all Market Authorization Holders (MAHs) of Pharmaceutical Products in India, which will be effective January 2018. This is a welcome change to the Indian pharmacovigilance (PV) system both for patients and pharmaceutical industries. This will eventually help to provide the real picture of drug-related events, thereby having a positive influence on patients in India. The new guidance is heavily influenced by European PV regulations.
According to the document: “MAHs are required to collect and process comprehensive safety information related to pharmaceutical products and report to regulatory authority within the prescribed timelines. Every MAH shall have a system in place that ensures overall quality of AEs/ADRs.”
As I read through this new document, I noted the following changes that companies need to be particularly aware of:
Especially for the drug manufacturers who do not yet have PV systems in place, implementing these changes can seem to be an insurmountable task. However, Bioclinica already has a presence in India in addition to the services needed to address the new requirements: help to establish and maintain a PV system and QMS as well as draft the PvMF and submit the PSUR, RMP and signal management results. In addition, our services cover the PvOI and PV audits. We can help you transition to the new requirements and improve the safety of your products.
If you are interested in learning more about how Bioclinica’s pharmacovigilance services can help you navigate through these new regulations, please contact us. You can also read the entire Pharmacovigilance Guidance Document for all Market Authorization Holders (MAHs) of Pharmaceutical Products.
Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.