In today’s world, anyone can open an online shop and start a business quickly from scratch, but this is not possible in the pharmaceutical sector. Drug manufacturing cannot be started without a factory licence, and deliveries require a marketing authorisation.
The aim of the marketing authorisation procedure is to guarantee efficient and safe drugs for patients and consistent quality across batches. The marketing authorisation process is strictly regulated and requires a lot of work. A myriad of documents and research results concerning the safety, effectiveness and quality of the product must be reported to the pharmaceutical authorities.
Even the slightest change can be a big slowdown
Industrial production and wide-spread use of a drug can only begin after the marketing authorisation has been granted. Gradually, the marketing authorisation holder accumulates more information on, for example, product safety, possible adverse effects, shelf-life and quality issues. All this information is collected and reported to the pharmaceutical authorities. The usability of the drug is continuously monitored, and necessary adjustments are made to the manufacturing process or use, for example, by adding warnings about groups of patients the drug is not suitable for.
If the marketing authorisation holder makes improvements to the quality or safety of the product after the marketing authorisation has been granted, the changes must be documented meticulously and approved by the authorities before implementation. Each change requires new test batches, validations and, in some cases, even new clinical tests if the change is expected to affect, for instance, the effectiveness or duration of effect of the drug. The aim of this procedure is to ensure that all changes are well-justified and documented.
Everything is done in the name of patient safety
The transportation of drugs, vaccine batches in particular, is also susceptible to organised crime. Each package must be equipped with a unique safety identifier to prevent forgery. For the manufacturer, this means yet another work phase that slows down the packaging of the products.
Selling drugs is much more complicated than selling other kinds of consumer goods. Before the product reaches the consumer, it has surpassed several milestones set by the authorities. The purpose of these milestones is to safeguard patients’ interests and ensure their safety.
At PharmaLex, our mission is to make the marketing authorisation process smoother and help pharmaceutical companies offer high-quality drugs to patients, at the time they are needed. Everything is done in the name of patient safety.