The mainstay of drug development is based on 3 parameters such as quality, efficacy and safety. In the last few blogs, we discussed the important quality and nonclinical safety aspects as per the ICH guidelines. Today we will focus on the efficacy guidelines that are determined by the evaluation of the clinical efficacy and safety…

The People’s Republic of China is a huge pharmaceutical market and big pharma companies have been trying to get into the Chinese market for past few years. Recognising the need for new drugs for the people of China with an opportunity to develop indigenous industry, Chinese government over the years have made several policy changes to accelerate…

A global initiative called the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together powerful regulatory agencies from Europe, Japan, USA, and pharmaceutical companies to create guidelines and discuss the scientific and technical facets of developing pharmaceutical products and registering them. The goal of the ICH is to advance…

Generic drugs are copies of the original branded drugs that are made available in the market once the validity of the patent protection of the branded drugs has expired. Generic drugs are identical to the original branded product as in contains the same active drug component, similar dosage form, potency, mode of administration, and intended…

The manufacturing of pharmaceutical products by a third party is referred to as third-party pharmaceutical manufacturing, often known as contract manufacturing. A pharmaceutical company enters a contract with a specialised manufacturing facility to manufacture pharmaceuticals, medical devices, or other pharmaceutical items on their behalf. This production plan is available for large scale industrial batch sized…

The centre for drug evaluation and research (CDER) is responsible for ensuring availability of safe and effective medicines in the country. CDER is thus entrusted with the responsibility of the public health. CDER is an important office under the United States Food and Drug Administration. The USA drug approval process for the pharmaceutical products includes a…

The development of drugs is a long process, and it takes 12-15 years to complete the development for regulatory submission. Thereafter, the regulatory approval, licensing, price negotiations etc. take another 2-3 years. Thus, the availability of medicines in the marketplace and its access to the patients is a long wait.  For certain health conditions and/…

Conducting clinical trials is a multifaceted activity involving several stakeholders and participants. Once the trial is finalized, the entire clinical supply chain services process gets activated. The entire process of clinical trial sourcing, producing, packaging, distributing, and managing requires meticulous planning and is referred to as "streamlining the clinical trial supply chain."…

The European Union has established a centralised regulatory authority responsible for authorising new medicines within Europe for human and veterinary use.  The European Medicines Agency (EMA) is the main authority that apart from new drug approvals coordinates with the regulatory authorities of the other member state countries of the EU as well as acts as…

The term "quality assurance" (QA) refers to a wide notion that encompasses all the critical steps in the production of pharmaceuticals. Quality Assurance ensures that the systems and processes used in production of a healthcare product guarantees <<product quality>>.  It is a system for monitoring product quality and process performance that aids businesses in maintaining…