Drug safety and pharmacovigilance are two faces of a coin

If one were to describe the relationship between drug safety and pharmacovigilance; the most concise way of describing it is by calling them as two sides of the same coin. The aspects of drug safety and pharmacovigilance are intricately and inseparably bound together. The whole purpose of pharmacovigilance is the assurance of drug safety. It is precisely to ensure drug safety, more than anything else, that pharmacovigilance has come into being as a discipline.

Pharmacovigilance (PV in drug industry parlance) is a means to ensuring drug surveillance across the entire process, right from procuring of raw materials to consumption and the effects of consumption. So, pharmacovigilance has to be implemented right across the chain of activities that go into drug manufacturing. It has to ensure compliance with regulation at all stages, namely before the product is manufactured, during the manufacture, and after it enters the market. It is an indispensable aspect of a Quality System, and plays a central role in inspections and audits.

Drug safety and pharmacovigilance are tied together at the level of regulatory bodies. There are different PV rules for different markets. For instance, while the FDA has its own set of PV guidelines; the EU has its own. A clinician or drug company involved in drug safety and pharmacovigilance has to be aware of the regulations in the markets into which the company's products are sold and has to abide by them.

In order to ensure drug safety, pharmacovigilance is carried out by agencies and governments across the globe in accordance with strict guidelines. Drug safety and pharmacovigilance pair together in a number of areas. These are some of them:

Clinical trial:The work of ensuring drug safety through pharmacovigilance starts at the stage of the clinical trial itself. Pharmacovigilance ensures that drug safety is built into the drug right at the clinical trial stage. PV sets out a number of processes and methods by which a pharmaceutical company involved in clinical trials has to go in order to ensure drug safety.

Marketing:PV is set out in the marketing stage of a drug, too. Drug safety brought about by pharmacovigilance is to be implemented at the marketing stage of the drug, including processes for its safe storage, handling and transit. Throughout all these stages, drug safety and pharmacovigilance guidelines are to be strictly implemented.

Governmental drug distribution:Drug safety and pharmacovigilance are also built in by governments in their interactions with each other. For instance, when the government of a country or an agency such as the UN is shipping drugs to another country to support a health program; utmost drug safety is ensured through the principles of pharmacovigilance.

Drug safety and pharmacovigilance in disease management:Several governments across the world, along with international agencies conduct disease control management or emergency handling across the globe, especially in developing countries. Pharmacovigilance is the means to ensure that the drugs administered at these programs are safe for human consumption.

Learn more on this topic by visiting: 

http://bit.ly/Safety-Reporting-in-Clinical-Trials-San-Diego

http://bit.ly/Validation-and-21-CFR-11-Compliance-of-Computer-Systems

http://bit.ly/During-an-Inspection

Rule relating to orphan drugs in Japan

Orphan drugs are those that are developed purely to treat rare diseases. The nature of orphan drugs is a little piquant: on the one hand, rare diseases affect very few people, but these cannot be ignored. On the other hand, orphan drugs, since they are so few in number, are not taken up usually by profit-driven organizations because they offer very less scope for large-scale production and monetization.

Different countries such as the US and Japan, and blocs such as the European Union have their own unique rules regarding orphan drugs. Rules relating to orphan drugs in Japan too, have their unique and salient features.

A look at the uniqueness of rules relating to orphan drugs in Japan

Orphan drugs in Japan are governed by five incentives:

• Subsidies
• Consultation
• Tax preferences
• Priority review
• Reexamination period review

Briefly, this is how each of these is carried out in practice:

Subsidies:The Japanese government has a fund of close to a billion yen that is used to subsidize orphan drug applicants. This grant, given through the National Institute of Biomedical Innovation (NIBIO), is aimed at helping manufacturers to ease the costs associated with development of orphan drugs in Japan.

Consultation:Under this system, the Japanese government offers priorities for manufacturers of orphan drugs in Japan. Called the Priority Consultation System; this process is offered in two ways:

One, when a sponsor of orphan drugs in Japan approaches the PMDA; the application is never rejected. Clinical data is discussed with each sponsor, at which all the aspects of orphan drugs in Japan are considered. Areas taken up for discussion include the number of patients, the intensity of the disease, the integrity and safety of the data, and so on.

Two, the fee category is also considerably lower for orphan drugs in Japan, with these manufacturers given about 25 percent discount. An application made for developing orphan drugs in Japan is put for consolation with a team of Technical Experts, who are selected from the Office of New Drug Review team, the Office of Cellular and Tissue-based Products Review team, and the Office of Medical Devices Review team. In addition, fee categories are drastically lower for orphan drugs in Japan when they are being developed by small companies or research institutes. These categories have a whopping 90 percent discount.

Tax incentive: Manufacturers involved in developing and manufacturing orphan drugs in Japan are given a 12 percent reduction as tax credits for expenses incurred during the NIBIO subsidy payment period.

Priority review:Manufacturers of orphan drugs in Japan are offered a priority review by the PMDA. While the median standard review time is one year for non-orphan drugs, that for orphan drugs in Japan is nine months.

Reexamination period review: The Reexamination period review for orphan drugs in Japan is also relaxed. It is fixed at eight years for orphan drugs in Japan, while this period is ten years for non-orphan drugs in Japan.

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Investigational New Drug Applications in the USA

Under current Federal law; any manufacturer wanting to market a drug in the US has to subject the drug to an approved marketing application before its transportation and/or distribution in the different States in the US. Since there is a strong possibility that the sponsor of a clinical trial may want to ship the investigational drug to clinical investigators across several states, the sponsor would ideally look to get exempted from this legal requirement. The mechanism through which this exemption issues to the sponsor from the FDA is the Investigational New Drug Applications in the USA.

That is, an Investigational New Drug Application is a request that the sponsor makes with the FDA for authorization to administer a biological product or an investigational drug to humans. This authorization needs to be secured before the product goes through interstate shipment. It also needs to happen before a drug that is not the same as an approved New Drug Application or Biologics/Product License Application is administered.

The logic behind filing Investigational New Drug Application

The entire idea behind filing an Investigational New Drug Application is to ensure the drug's safety for use in humans. This leads to the embarking of steps for its commercialization. The Investigational New Drug Application is often the first step that paves the way for further actions such as data collection to reinforce its safety factor. An Investigational New Drug Application is a sort of guarantee that when the drug that is at this stage of studies is administered on humans; they do not carry risks.

When does the FDA's role begin?

The FDA's role in the Investigational New Drug Application begins at the time when the sponsor wants to test the effect on humans of molecules that is identified earlier.

Types of INDs

There are three types of Investigational New Drug Applications:

What should an Investigational New Drug Application contain?

An Investigational New Drug Application should contain the following:

• Studies done to test animal pharmacology and toxicology
• Information concerning manufacturing
• Information about the Investigational New Drug Application's clinical protocols and investigator

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A word about the Drug Development Process

The heart of all the stages a drug undergoes is the drug development process. Within the drug development process lies a description of each and every step that goes into the development of the drug. The FDA describes five steps that the drug development process has to undergo:

One:The drug's discovery and development

Two:Preclinical research

Three:Clinical research

Four:FDA review

Five:Post Market safety monitoring by the FDA

Stage One:This stage is when the discovery and development that leads to the drug development process of the drug takes place. Innumerable compounds are tested for their ability to get developed into a drug at this stage. Scientists and researchers carry out this stage of the drug development and select a few of these for further study. Protocols of the selected compound are put in place to identify its viability for getting developed into a drug. Core aspects that go into this stage include the manner of its absorption and distribution in the body, side effects, the proper form and dosage, its reaction in varied demographic clusters such as gender, age, race and so on.

Stage Two:In vitro and in vivo tests are carried out at this stage for setting the requirements of the drug for complying with Good Laboratory Practices (GLP) and determining whether it does or not. An important reason for this stage of drug development process is that it offers information on critical aspects such as toxicity of the drug. These results lead scientists to determine if the drug can be, or has to be tested on humans.

Stage Three:Drug development process at this stage is done to decide the precise manner in which the drug needs to be tested on humans, and makes way for the investigational new drug process (IND).

Stage Four:Following the IND process; the drug has to start the New Drug Application (NDA) process. The NDA, which is the complete history of the drug from the earliest stage, opens up the drug for FDA approval. The FDA approval is the final benchmark that the drug needs if it is to be marketed. This is a very lengthy process and, depending on the type of drug, can take years.

Stage Five:Although this is formally the point at which the FDA approves the drug for marketing; the drug development process goes on. The FDA monitors the product much after its entry into the market.

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