Pharmaceutical Sector Regulatory Practices


Science / Health

The pharmaceutical industry uses high-level technology, comprehensive knowledge and is heavily regulated. The regulations control drugs in all aspects and all industries involved in the processing of drugs. It covers all prescribing physicians, retailers, wholesalers, and manufacturers of drugs. Some drug requirements such as quality, safety and effectiveness are not observable hence require a pharmaceutical regulatory affair specialist to check on the regulatory compliance of the products. The specialists work with companies and organizations to ensure that their products apply the given regulations by a regulatory body or government agencies.

The pharmaceutical sector has both research and development and marketing of drugs. The regulations are always fluctuating according to the cost of research and development. An innovative and research-based industry that develops new pharmacy products incurs high costs in research and development. This is required to ensure that every new product complies with the regulation standards on the quality, efficacy, and safety of every drug produced. Regulatory bodies ensure that all pharmaceuticals show the efficacy and monitoring of the whole production process and also control the promotion and marketing of the products. Pharmaceutical research and development always demand a large amount of investment and therefore production companies are given intellectual property rights protection on income flows. Advertisement and promotion of drug approval take long, is expensive, and is a slow process hence minimizing the income returns.

There are also pricing policies that control the prices of drugs in the market. The prices are determined by various factors. For drugs with usable substitutes, the prices are always close to the lowest priced product with the same function. Drugs with no or few substitutes have a higher pricing value. Some prices are set according to the international values of similar drugs. These prices can also be affected by other industries change in controls such as board freezing prices and annual rate limits. The wholesale sector is complicated and has very many dealers. The prices are therefore controlled from the wholesale value of different drugs. Some countries have regulations that promote monopoly such that a pharmacy is owned by a person to prevent chain pharmacies.

The controls are also applied to physicians and pharmacists who prescribe drugs to patients. They ensure that patients receive services at cost-effective rates. The prescribing guidelines dictate the type of doctors allowed to administer a specific medication and some even give budgets to physicians. In some cases, the controls ensure an averaged and standardized amount payable to a health caregiver since the rates have an impact on pharmaceutical industries and health inputs. Doctors per capita payments are also controlled, and, in most cases, they are expected to purchase the drugs on behalf of their patients. This helps to reduce competition among doctors hence ensure that people get quality services. 

Pharmacists are compensated according to the products they sell, and this increases the chances of them raising the prices instead of lowering them. In such situations, the regulatory government agencies strive to provide alternative bio-equivalent products that are cheaper.

The regulations are harmonized globally by the global pharmaceutical industry. Since different countries have different regulatory practices, some pharmacies exploit such opportunities to fool the system. Game playing the regulatory system is prevented by the establishment of internationally applied practices to avoid opening of various markets with ease. Governments strive to enforce good regulatory practices to fulfil public interest. Their regulatory controls are the determining factor of the healthcare division. To ensure good regulatory practices ensure that.

  1. Enforcement of a scientific-based structure to ensure implementation of regulations. The analysis specialists provide inspection records, dossiers, and manufacturing facilities.
  2. Updated communication on any variations made on the laws and regulations. Pharmaceutical industries must be made aware of what regulations are being enforced and be included in the policymaking process.
  3. Regulations and laws should be consistent and standard. Before establishing a rule, it is beneficial to consider all pros and cons of its application to ensure clear expectations. Every drug industry should have a regulatory body or personnel that counterchecks that they meet set standards.
  4. Alignment of regulatory practices with global regulations is important. The body considers the allowable standards by international bodies such as WHO and any other global guidelines. The production sponsors are requiring proving that they comply with the regulations by providing evidence of quality data, technical standards, and consistent requirements.
  5. Regulatory bodies are expected to show transparency in their actions for trust gain and rule application. The regulations and metrics should be drafted and made available to the public.


Future research is targeted to help update and formulate new effective regulations for pharmaceutical industries. The regulations have been put in place to help the country learn valuable lessons and get educative information. Regulatory bodies’ laws are affected by several factors and service providers and receivers. Most pharmaceutical industries ensure regulations are fulfilled and applied by involving an internal regulatory affairs specialist.  

Angela is a senior editor at Dreniq News. She has written for many famous news agencies.