Pharmaceutical & Biotechnology
Commercial drugs and their products are manufactured by pharmaceutical companies and they are generally patented. Drugs can be classified according to their route of administration, chemical properties and biological systems they affect.
Control and authorization processes have become stricter for the pharmaceuticals with laws and regulations introduced as a result of many violations of GMP rules.
Rapid developments in technology have introduced new challenges for authorities. In order to minimize the effects of this situation, authorities have been revising and updating regulatory standards and requirements.
Expectation of authorities has evolved from previously applied authorization processes consideringonly quality control test results to Quality by Design concept.
Common and standard review requirements have been developed by the international council of (previously conference on) harmonization with regard to of regulatory requirements and application format of ICH-CTD.
There are many reports and publications available in literature indicating that the earlier medicinal products, mostly chemical compounds, were obtained from natural sources.
Synthetic and semi-synthetic pharmaceuticals, which are called conventional and still are prepared in various pharmaceutical dosage forms at present , are defined as low-molecular weight molecules.
The qualities of these chemical drugs have been improved during the past number of years and they are used for the treatment of many diseases.
Elucidation of DNA structure provided great contribution to this development. Biologics include many product types; such as: DNA vaccines, blood and blood components, allergenics, somatic cells, gene therapeutics, monoclonal antibodies, fusion proteins, tissues and recombinant therapeutic proteins. Biologics are large molecules derived from live cells.
Biosimilar products are referred to similar biological medicinal products. These are new versions of available biopharmaceutical products with expired patents and are mostly consist of proteins. “Guidelines for Biosimilar medicinal products” were issued in Turkey in 2008 and the regulatory criteria for assessing biosimilar drugs are determined accordingly. Drug substances of biosimilar products are similar to the respective biological medicinal reference drugs in a molecular and biological respect Biosimilars are not considered or accepted as generic products. The reason being that biotechnological products are manufactured potentially from different live organisms and can have some minor differences in the products . Biosimilar and biological reference drugs are generally used to treat the same disease with identical strength and dose, pharmaceutical forms, and routes of administration. Biosimilar products differ from the biological reference products in minor compositional variations along with commercial name, appearance and packaging.
Generic drugs are manufactured with drugs developed by originator (innovator) company as a reference. Generics are drugs that have the same properties as the original drugs, provide the same treatment to patients and manufactured only after the patent protection periods of original drugs have expired. A generic drug should have the same efficacy, quality and safety with the originatorr’s drug. Bioequivalence of a product , which contains the same drug substance as of the originator’s product in identical doses, but manufactured by different organizations (companies), should be proven in order to be prescribed interchangeably to the originator’s drug. As in all trials performed on humans, bioequivalence trials are performed according to the rules of “Good Clinical Practices”.
OTC (Over the Counter) Products
All over the world, the tendency of switching from prescription drug status to over-the-counter (OTC) status is accelerating for drugs with “proven efficacy and safety”. OTC drugs constitute approximately 15 percent of the world’s pharmaceuticals market with a sales figure of over 100 million dollars. OTC drugs are used for the treatment of minor discomforts experienced frequently in everyday-life without the intervention of a physician. The OTC products are usually free from medical drawbacks and may be taken at the recommendation of a pharmacist. They are safe drugs with accepted efficacy for the indications, provided that they are used for a short period of time. In order for a drug to become an OTC drug; a drug should contain three features as per ‘Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication’ issued by World Health Organization on 2000:
- Drug substance: Intended dose of drug substances should have low toxicity.
- Use: Intended use should be suitable for self-medication. Use of the product should not unnecessarily delay the diagnosis and treatment of a disorder that requires medical attention.
- Product properties: The product should not have any properties that would render it undesirable. It should not require the supervision of a doctor for monitoring of drug treatment. It should not pose addiction threat and hazard risk. It should not show any adverse characteristics such as interactions with commonly used foods and drugs that could result in an serious adverse reaction
Herbal Medicinal Products
Authorizations are required for herbal medicinal products/ preparations that protect human health, and have a history of conventional use. The following criteria are usually described for the application to obtain regulatory approval for conventional herbal medicinal product(s) : (i) products are in use via oral route, externally or through inhalation; (ii) has special applications only suitable with the dose and posology determined in specific manner; (iii) has specific indications conformable with the conventional medicinal products; (iv) are designed and intended to be used without diagnostic control, or of a physician, prescription or treatment follow-up in terms of composition and administration purposes; and (v) consists of medicinal plants bibliographically proven to be used for at least fifteen years in Turkey or in European Union while thirty years in other countries.
Cosmetics are any substances or mixtures that are prepared for application on the outer parts of the human body; skin, nails, hair, lips, outer genitalia, teeth and/or mouth mucosa. The only or the main purpose of which is cleaning those parts, giving off scent, changing its appearance, protection, keeping the site in good shape or enhance body odor. Components of cosmetics are chemical substances or mixtures of synthetic or natural origin that are used in the preparation of the cosmetic product, apart from perfume and aromatic compounds.
Food Supplements/ Functional Foods
Functional foods are not evaluated as drugs. Although they modify the physiological functions in the human body in a positive manner and show their effect on normal body functions by regulating, supporting and/or protecting routes of administration in concordance with normal human physiology. Functional foods can regulate or improve body functions within normal limits for improving human health or reduce factors known to be associated with disease. Functional foods are products intended for consumption as a part of a normal diet and they are in food form. Meanwhile, drugs are generally taken under the supervision of a medical doctor, in specific doses, and as a part of a controlled diet. Functional foods are evaluated within the scope of food regulations. Food supplements are taken in pill or capsule form similar to drugs, however these cannot be presented to treat or prevent diseases and are controlled with food laws. For food supplements, an authorization is obtained from Ministry of Food, Agriculture and Livestock under the name “food supplement”. Food supplements are not drugs and do not have a therapeutic effect for diseases. Products that have been authorized by T.R. Ministry of Health and claimed to have an indication are expressed as drugs.
Radiopharmaceuticals are those substances used for treatment and/for diagnostic purposes that are in composite, mixture, solution or compound form and contain radionuclides. They emit single or multiple ionizing radiations, and thus their nuclei degrade on its own.
Radiopharmaceutical products are products prepared for use with medical purposes and contain one or several radionuclides upon being ready for use. Radiopharmaceuticals have a heterogeneous structure and/or composition since they can bear one or several radioactive isotopes. Regulatory processes for radiopharmaceuticals are assessed similar to other medicinal drug products. Radiopharmaceuticals have a wide area of use. If they are used for diagnostic, they are categorized under “Single Photon Emission Computed Tomography, SPECT” and “Positron Emission Tomography, PET” groups. Unlike conventional medical drug products, they contain very small amounts of active ingredients; therefore they do not have properties that trigger pharmacodynamic effects. While complete compliance with current GMP – GRP rules and regulations are essential for the manufacturing of radiopharmaceutical products, appropriate protection of employees, public and the environment from radiation exposure are mandatory requirements from regulatory authorities. Radiopharmaceuticals with short half-lives must be kept nearby as these can only be administered to patients in less than 20 minutes. (e.g.: C-11 or Rb-82). Radiopharmaceuticals with moderate half-lives may be transported to hospitals and imaging centers in short distances. (e.g.: F-18 / 107 min). Radiopharmaceuticals with a long half-life are kept in a manner to allow their shipment from manufacturing site to other countries. (e.g..: Y-90 with a half-life of 64.1 hours or I-131 with a half-life of 8.02 days). When evaluated from a medicinal product perspective, many ready-to-use radiopharmaceuticals are in “solution for injection” form while a small number of products are in “tablet or capsule” form.