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Are you currently planning an eCTD (electronic common technical documents) submission to Australia? If you are intended to, then take a pause and look out for the changes which are to be done while preparing your dossier for the region. Therapeutic Goods Administration (TGA) of Australia has rolled out a new mandate to use latest version 3.1 Module 1 Specification for...
On April 5, 2017, the European Commission has approved the new Medical Device Regulations (MDR) - 2017/745-MDR and 2017/746-IVDR, which have come to effect in force (EIF) from May 25, 2017.
The primary reason to revamp the preceding medical device directives (MDD) was aimed at enhancing compliance standards for the device manufacturers, notified bodies (NBs) and other stakeholders. As...
The United States Food and Drug Administration’s (USFDA’s) Pregnancy, Lactation and Labeling Rule (PLLR), which came into effect in June 2015, establishes a labeling standard for prescription drug products which can be used during maternity and lactation. In addition, to overcome the current prescription drug labeling information, the new rule focuses more on content and format changes under...
An Investigational New Drug (IND) sponsored by a corporate entity is considered as a ‘Commercial IND.’ Center for Drug Evaluation and Research (CDER) has the authorization to designate IND as commercial if it finds the intent to commercialize the drug in future. In the United States, INDs must be registered with the Food and Drug Administration (FDA). As part of the implementation of FDA’s...
Finished drug products contain minute amount of impurities which find their way into drugs at various junctures of manufacturing. They can be residual catalysts from synthesis or might get picked when in contact with manufacturing equipment, containers or other sources. These impurities are generally referred to as ‘Elemental Impurities.’ Their presence in drugs is deemed subject to regulation...
Effective communication can bridge information gaps between two different ends of a process. With so many processes involved and with a need to communicate accurate safety information to the end user, the Pharmaceutical industry must employ utmost caution when taking its products to market. Right from product development to the stage of packaging in cartons, they are required to safeguard the...
In Europe, the demand for medical devices has increased by many folds. While medical device manufacturers are relying on the market demand, they must also make sure how their product is considered and classified in Europe. The fact that the device is accepted in other countries like USA, Canada or Japan does not always have to be conformed to the European Device Directive (EDD). Thus, it is...
We are all aware, that the United States Food and Drug Administration (USFDA) has extended compliance date for Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format, i.e., 5th May 2018. With less than two months in hand, the first and foremost question every applicant should ponder upon is, what are the DMF Type-wise requirements and how is...
Therapeutic Goods Administration (TGA), the Australian regulatory authority has approved a new product information (PI) form on 8th November 2017. The commencement date of the new PI form was 1st January 2018, with a transition period of three years ending 31st December 2020.
The rationale behind the new update is to ensure that critical clinical...
As it has been known, for medicines, EMEA require certain documents (including the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and labels) which should be submitted in English as a first draft for necessary approvals. If there are any changes required in the draft version, they should be executed and resubmitted in the English draft. Upon approval of the...
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