The FDA will implement the international approval standards for generic drugs. Just submit an eCTD to be approved globally at the same time. Yanhe Scientific Instruments (Shanghai) Co., Ltd. Professional Drug Stability Test Chamber Manufacturer Product Order Hotline 13601725845 Zhao Gong

The FDA implements the international approval standards for generic drugs, and an eCTD can allow products to be launched globally. Most Americans suffer from high drug prices, but in many cases, patients do not need these "high-priced" drugs. That's why drug prices can become a public health issue, and it's why the FDA introduced the Drug Competition Action Plan. The program focuses on the following three areas: increasing generic drug competition, improving generic drug accessibility, and promoting the development of high-quality and inexpensive generic drugs.

While we have made substantial progress in promoting generic drug competition, we have addressed many of the hurdles to the approval of generic drugs. The approval of many complex generic drugs has become possible by accelerating the review and approval speed and cutting off the gaps in the utilization policy of branded drugs to extend the drug monopoly time. However, we still have a lot of work to do. So before we talk about the drug competition action plan, we are opening up some new policies, and we will restart the 2019 plan and other related initiatives. Foremost among them is a new initiative the FDA has proposed to ICH to establish a global generic standard for generic drugs.

FDA Commissioner, Dr. Scott Gottlieb's idea is very straightforward. We hope to implement internationally harmonized scientific and technological standards for the development of generic drugs. Generic drug development companies should be able to apply to multiple countries for approval at the same time under the condition of following a single global development process and adopting common application requirements. This makes it easier for generic drug companies to submit applications separately in each country or region. Generic drugs only need to be approved by one of the regions before they can be recognized by the FDA. The level of competition for generic drugs. For example, the electronic version of the Common Technical Document (eCTD) adopted by the FDA has gradually developed into an international application data format. In addition, the cost of developers will be greatly reduced, because they no longer need to submit to each country or region. The data and information requested by them.

But for us, we need to do more work next to standardize scientific and technical requirements to generate data in the same format. The ultimate goal of this global harmonization of scientific and technological requirements is the adoption of a single global development process to support the simultaneous approval of multiple multinational regulatory authorities, and the harmonization of these requirements is a prerequisite for the future goal of global harmonization of high-quality generic drug approvals.

Internationalized generic drug standards can increase competition At present, the production standards of different countries may be different, and the test items required for the approval of generic drugs in different countries are also different. For example, for the same drug, the dissolution methods and acceptance criteria required by FDA and EMA are different. Differences may exist. In generic drug development, the lack of coordination of these essential elements reduces the opportunity for generic drug development companies to submit applications in multiple jurisdictions using the same data and information, resulting in a substantial increase in the cost and complexity of generic drug development. Therefore, generic drug development companies with limited resources and capabilities can only choose to submit generic drug marketing applications in limited countries or regions. And the drug market of the countries or regions abandoned by them will not be able to achieve drug price reduction due to the lack of fierce competition from generic drugs, and even cause the risk of drug shortages.

Based on the globalized generic drug development and the basic commonality of technical requirements between different regulatory agencies, a more harmonized generic drug development process is expected to be realized.

The FDA recently conducted a preliminary analysis using IQVIA MIDAS international data to explore the potential to expand generic drug availability and increase market competition outside of the current market. In addition to the U.S. market, the FDA also used 2017 data to sample nine countries including France, Germany, Greece, Poland and the U.K., Japan, Canada, Switzerland and Australia. In particular, the FDA also explored whether these countries have access to generic varieties that are currently unavailable.

First, the FDA inquired about the accessibility of the top 100 generic drugs in the United States in terms of prescription volume in other 9 countries. The results found that the accessibility of generic drugs in these countries lags behind the United States to varying degrees, among which Canada has the highest accessibility. Only 5 are inaccessible, and Japan is the lowest with 25 inaccessible. The FDA then searched for the 400 lowest-selling generic drugs in the U.S. because these products are the lowest-selling in the U.S. and would be less accessible in other countries. It was found that these generics were only 35% available in nine other countries, and 65% of the varieties appeared to be unavailable. The results of these preliminary analyses suggest that increasing the availability of generic drugs in the United States and other countries is very likely.

These analyses focus on the availability of generics in different markets, and do not address the question of how many generics one or two companies can offer—a problem with market structure that could raise the risk of rising drug prices and shortages. Simplifying the development of generic drugs through globally unified development standards can effectively reduce the barriers to generic drug access and increase the number of generic drug products to mitigate these risks.

In conclusion, harmonization of scientific and technical standards can benefit in several important ways:

Allowing generic drug development companies to use the same set of development data to support generic drug approvals in different regions can simplify the generic drug development process and benefit from development costs. For example, globally harmonized standards can reduce the number of trials (such as bioequivalence), allowing multiple regulatory agency approval requirements to be met with only a harmonized study;

Implementing common standards that can simultaneously meet the requirements of multiple regulatory agencies can effectively improve the consistency of global generic drug quality;

More information exchange and sharing opportunities can be obtained between sister regulatory agencies, which can effectively improve regulatory efficiency and reduce regulatory costs;

Increase the size of the global generic drug market and attract competition from different generic drug development companies;

Increase the use of generic drugs through access to multiple markets to reduce the fixed costs of generic drug development.

FDA's Proposal for Global Generic Drug Standards

In order to achieve the above goals, the FDA has submitted a related proposal to the ICH, recommending the development of an international unified technical standard guide for the development of generic drugs. ICH countries are the scope of implementation of uniform standards for pharmaceuticals, including new and generic drugs. While many ICH guidelines already apply to generic drugs, ICH has previously focused on new drugs. Therefore, there is still a lack of uniform standards specifically for generic drugs. We anticipate that ICH will review the FDA proposal and hopefully approve it at the next meeting in November 2018.

By working with regulators and the pharmaceutical industry within ICH, we can negotiate areas of common concern. And we can develop guidance to help simplify the generic drug development and approval process in multiple regulatory regions. In particular, to fill the gaps in this area, we recommend that ICH develop a series of guidelines to determine the equivalence (eg, bioequivalence) of generic and complex generics and brand-name drugs. These activities also recommend the establishment of a uniform bioequivalence trial design, as well as additional bridging studies that need to be performed between generics using different reference products (RLDs).

While we pursue a uniform international standard for generic drugs, the FDA will pursue a rigorous, science-based gold standard. These initiatives aim to lower barriers to entry for generic drugs globally and provide greater market opportunities for U.S. generic drug companies. We want to improve the economic framework for the development and manufacture of generic drugs, and we want to promote competition among generic drugs. To achieve the goal of uniform global approval of generic drugs, FDA will consider the feasibility of using a common reference standard in generic drug development.

While lowering the entry barriers for generic drug companies around the world, it also brings huge business opportunities. FDA can support the stable development of the generic drug economy and encourage capital investment in this field. At the same time, American consumers are facing There will be more competing products.

Access to medicines is a public health issue. We believe that a globally unified generic drug technology standard will promote a larger generic drug market, generate more intense generic drug competition, lower drug prices, and increase patients' access to high-quality drugs. Our work in this area is not limited to these proposals or generic drugs, we will also work to advance medical progress and competition among medicines. We will work with our international regulatory partners to increase drug competition by accelerating drug innovation and generic drug development.