Drug manufacturing companies may or may not participate in innovative research. They may also be wholly local property or belong to multinational companies or be partially local and partially multinational property. There are a few cases of drug-producing NGOs.
The nature of the manufacturing company will determine its attitude towards policies aimed at changing public and private functions. Thus, the international research-based industry strongly opposes price control since its profitability depends on the launch of innovative products at competitive prices. On the other hand, price control measures may be less problematic for local companies that manufacture generic products by carrying out their activity in a moderately competitive market. Attitudes towards proper manufacturing practices can also be very different between some agents and others.
The development of a new drug is not an easy task. Most pharmaceutical companies can take between 12 and 15 years from when they begin to investigate an active substance until it is available to patients.
Drug Post Launch Activity is a very extensive process that requires a high economic investment by pharmaceutical companies. Mainly the process can be summarized in 4 steps:
1. Discovery and development
In this first stage, the therapeutic targets that mark the development of the research are identified. Targets are chemical substances, in most cases, proteins that are associated with a disease. Once the target has been identified, its mechanism is studied, and that is how it works and influences the development of the disease.
After this analysis, various tests are performed to see which compounds have the desired effect on the selected target. Once analyzed, potential compounds are identified; that is, those that are believed to have the potential to be developed as future effective medications.
2. Clinical research
Clinical research refers to studies or trials that are conducted in humans to test how the drug candidate interacts in the human body. Before starting this phase, researchers must deliver to the regulatory agents, Research Process of Drug Post Launch Activities for its acronym in English. The results are presented in the pre-clinical investigation.
Clinical trials are carried out in phases ranging from small to large scale:
Phase 1: The experimental compound is administered to a small group of patients and healthy volunteers to assess the safety of the treatment, determine the necessary doses, and identify the side effects.
Phase 2: In this phase, the experimental treatment is administered to a larger group of people to identify its effectiveness and to evaluate its safety further.
Phase 3: The drug is administered to large groups of patients to confirm the efficacy of the compound, monitor side effects, and compare it with other treatments used for the same disease.
Phase 4: These are clinical trials that are performed after the respective regulatory agents have approved a medication. The objective of these trials is usually to provide additional information about treatment, risks, and benefits, among others.
3. Registration and authorization of the authorities
Once the researchers have the results and analysis of the clinical trials, they proceed to send the NDA, New Drug Application for its acronym in English, to the corresponding regulatory authorities. The NDA contains all the information about the medication where its safety and efficacy are demonstrated in the population studied.
If the authorities see the safety, efficacy, and quality of the new treatment tested, authorization is granted to market it.
4. Launching and safety monitoring
Once the product is marketed, new clinical trials, such as Phase 4, can be carried out to determine its effectiveness for other indications, reformulate the medication to improve it, or continue collecting information on adverse effects.