Pharmaceutical Regulatory Update can be broadly divided into two categories: U.S. based and international based pharmaceutical regulations. This division is basically based on the cost benefit to the sponsor, i.e. whether the proposed rules will increase the cost of developing the drugs in question or whether it will allow them to benefit economically from their research efforts. The main point of discussion is that the costs are so high that any increase would be unacceptable for most pharmaceutical manufacturing plants. However, the benefits far outstrip any concerns for cost benefits and therefore, an analysis must focus on whether the proposed rules are justified by the benefits they will ultimately give to the pharmaceutical industry.
In the US, the pharmaceutical regulatory updates are applicable only to the commercialization of drugs manufactured in the US. However, since the FDA does not regulate foreign manufacture of pharmaceuticals, the FDA has issued statements calling for submissions regarding the scheduling of Chinese origin active ingredients in these drugs. China has strongly rejected such claims, pointing out that the Chinese government has signed an agreement with the European Union not to restrict the use of Chinese ingredients. So far, this policy has not been put into practice. Nevertheless, the European Union has threatened to do just that if the US FDA does not agree to license its new anti-tuberculosis drugs based on Chinese origin.
Such a move would have serious consequences not only for the US pharmaceutical market but also for the rest of the world. The European Union has so far been the only regional body to take such action. On the other hand, a Chinese rejection of a new drug application from any other country would result in the European Union imposing similar measures. Thus, the current dispute in the pharmaceutical market between the US and china is not isolated. Rather, it is a reflection of how globalization is impacting the pharmaceutical industry.
Another important aspect of the recent regulatory updates is the extension of the indications allowed for biopharmaceuticals. Previously, Biopharmaceutical plants could only apply for a limited number of indications, such as AIDS, diabetes, cancer, etc. But now they can apply for approvals for all conditions, which includes chronic and systemic diseases, too. This change in the indications policy has significantly impacted the business practices of Biopharmaceutical plants. It has forced the companies to re-think their strategies in terms of their business growth and prospects, and that's why there have been so many in-house restructurings and distractions taking place in recent times.
There are three key points which the recent set of FDA Regulatory Updates meant for Biopharmaceutical plants: First, there was a ban on the use of some chemicals in their products, which includes antimicrobials and cytotoxic agents. Second, the manufacturing industries were notified that they need to submit plans for protecting their facility from external contamination and risk exposure. Lastly, the pharmaceutical industry was reminded that they need to submit an annual pda technical report on the clinical trials they conduct to the FDA. These updates are meant to assist the FDA in assessing the efficiency and safety of these medical devices. The FDA also pointed out that the quality control measures must be verified before releasing new drug or medicine, and that is why clinical trials must be carefully monitored before and after its commercial release.
In essence, these updates aim at improving the pharmaceutical quality control and ensuring safety of biotechnology products.So, if you want to know what the recent FDA regulatory updates meant for Biopharmaceutical plants, then the first point which you should read is the FDA notice about the proposed ban on the use of Methylxanthines in Biopharmaceuticals. Then, you should read the FDA notice about the new notified standards on Compositors, and final guidelines on the disclosure of package leaflets. Lastly, you should read the guidelines on the submission of drug application, and package leaflets on how to read them. To get a detailed overview of this topic, see here: https://en.wikipedia.org/wiki/Regulation.
