Common Technical Documentation (eCTD)

Pharmaceutical and Chemical companies have to comply with innumerable regulations. They have to submit documentation to several regulatory agencies. The Federal Drug Administrations, Product Licensing Authorities, Product Brand Name registration authorities are some of these agencies.

The opening up of the generic markets after the onset of the WTO patents regime from January 2005 and the patent expiry of a huge number of products, Getting-it-Right-First-Time, has become critical to the success, growth and profitability of Pharma and Chemical companies. While development of the product using Non-Infringing Processes (NIP) and the registration of the product with the NIP creates opportunities on one hand, being the first to get the Abbreviated New Drug Application (ANDA), the Drug Master Files (DMF) and similar approvals and getting exclusivity to sell the products along with the original innovator in new markets swells the coffers of the companies who Get-it-Right-First-Time.

To Get-It-Right-First-Time, the companies have to ensure that the common technical document (CTD) is accurate and error free. When documents are accurate and error free, the approvals happen faster, when the companies get faster approvals, they can sell their products in newer markets, hence increasing the sales volume and top line of the company.

The International Conference for Harmonization of Standards (ICH) has defined the Electronic Common Technical Document (eCTD) that describes the specification for the globally acceptable electronic registration process from industry to regulatory authority.

The documents submitted using eCTD get validated as per the requirements of the ICH guidelines and the specific guidelines for each country, where the CTD is submitted, hence enabling faster approvals. Pharma and Chemical companies who adapt quickly to submission in electronic CTD (eCTD) form are hence at an advantage for getting approvals without delays.

Structured Product Labelling (SPL)

The US FDA has made it mandatory for companies submitting ANDAs to also provide product leaflet information in electronic form. FDA has specified the format in which the leaflet information has to be provided so that it can be made available on their website.

The European Union also has mandated such a requirement under the terminology PLM.

The data has to be submitted in electronic form in a format that is compatible with the format of the software used by the individual country’s regulatory authorities.