Driven by the wave of globalization, pharmaceutical companies going global has become an important trend in the industry. This not only brings broader market space for enterprises but also accelerates the integration and innovation of global pharmaceutical resources. However, pharmaceutical companies face many complex situations and challenges in the process of going global, and they need to comprehensively and deeply understand what relevant knowledge is required to formulate reasonable strategies.

I. Background and Driving Forces for Pharmaceutical Companies Going Global

1.Market Expansion Demand: The competition in the domestic pharmaceutical market is intensifying and gradually becoming saturated, while the overseas market is huge, especially in developed countries and regions such as Europe and the United States. Going global can expand market share and increase revenue and profit.

2.Policy Support and Encouragement: The state has introduced a series of policies to support the international development of pharmaceutical enterprises, such as financial support for innovative drug research and development, tax incentives, and simplified drug export approval processes.

3.Enhancing Enterprise Competitiveness: Entering the overseas market enables access to advanced technologies, management experience, and R&D concepts, which promotes the improvement of their own technological innovation and management level and enhances global competitiveness.

II. Types and Characteristics of Drugs for Export

1. Active Pharmaceutical Ingredient (API): The Key Component of Drugs

The API is the main active ingredient of a drug, which can be directly used for drug production or combined with other chemical components to form a preparation. It can be a chemically synthesized API, such as the common aspirin API, or a biologically obtained API through biotechnology means, such as the API of monoclonal antibody drugs.

2.Pharmaceutical Preparations: Direct Treatment Products for Patients

Pharmaceutical preparations are drugs that can be directly taken when sick or going to the hospital, including various types such as tablets, granules, and injections. Preparations can be either chemical drug preparations made from chemical APIs, such as Compound Paracetamol and Amantadine Hydrochloride Tablets, Ganmao Qingre Granules, etc., or biological drug preparations made on the basis of biological APIs, such as Recombinant Human Interferon α - 2b for Injection, some orally taken intestinal probiotic preparations, etc.

III. Mode Selection for Pharmaceutical Companies Going Global

The modes for pharmaceutical companies to go global mainly include independent going global and cooperative going global. Independent going global requires pharmaceutical companies to independently conduct business in the overseas market with their own strong R&D, production, and sales capabilities. It requires in-depth understanding of the overseas market, regulations, and the establishment of sales channels, and places extremely high demands on the comprehensive strength and international experience of the enterprise. Cooperative going global includes licensing, where pharmaceutical companies license their achievements to overseas parties to obtain benefits and reduce risks; joint development, where both parties cooperate to accelerate the listing of drugs; and strategic investment, where equity and cooperation opportunities are obtained to expand the overseas market. Enterprises should carefully select the going-global mode suitable for themselves based on their own resources, capabilities, and strategic objectives to enhance their competitiveness and development potential in the international market.

IV. Market Characteristics and Approval Points of Going-Global Destinations

For pharmaceutical companies going global, different regional markets have different characteristics, which deeply affect the strategic layout of pharmaceutical companies. Understanding the characteristics of each destination market can help pharmaceutical companies accurately position themselves and effectively formulate going-global strategies to achieve international development goals.

1.United States:

The United States is one of the largest pharmaceutical markets in the world, with drug sales accounting for nearly one-third of the global total, and has huge market potential (large market size). Moreover, the government and enterprises in the United States invest a large amount in pharmaceutical R&D, possess world-leading scientific research institutions and innovation capabilities, and provide a good R&D environment and technical support (high R&D investment). The US Food and Drug Administration (FDA) has strict drug approval and supervision requirements, demanding strict clinical trials and quality inspections to ensure safety and effectiveness. In the training of the pharmaceutical field, the FDA is an important institution often mentioned. Domestic pharmaceutical companies often prefer to list in the United States and need to apply for registration and listing procedures with the US Food and Drug Administration (FDA) (strict supervision).

2.Europe:

The European pharmaceutical market is mature, with a complete medical security system and drug supervision system, and has high requirements for drug quality and safety. At the same time, as an economic integration organization, the European Union has a certain coordination mechanism in drug approval and supervision. For example, the European Medicines Agency (EMA) is responsible for coordinating the drug approval work of EU member states, providing convenience for the listing of pharmaceutical companies in the European market (regional integration advantage).

There are two authoritative organizations in the EU, the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM).

The approval procedures of the European Medicines Agency (EMA) are as follows:

(1)Centralized Procedure (CP): It has the largest coverage. Once approved, the drug can be marketed in all EU member states plus three European Economic Area countries, namely Iceland, Norway, and Liechtenstein. It has a unified trade name and a set of unified product characteristics summaries, labels, and instructions, and has 24 language versions of EU countries, which helps enterprises quickly expand the European market.

(2)Decentralized Procedure (DCP): Approval in at least two EU countries, and the application process can be initiated simultaneously. The country that processes the application first becomes the reference member state, and the other countries are the concerned member states.

(3)Mutual Recognition Procedure (MRP): After a Chinese pharmaceutical company completes the drug registration and approval in one country, it can use almost the same registration documents to apply in other countries. If there are differences, they will be reported to the EMA for mediation.

(4)National Procedure (NP): Domestic pharmaceutical companies can choose the main target listing country, such as France, and let the local approval authority of that country handle it.

The European Directorate for the Quality of Medicines & HealthCare (EDQM):

The EDQM belongs to the Council of Europe. It writes and promulgates the European Pharmacopoeia (EP) and issues Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP). Domestic API enterprises often prefer to apply for CEP when going to Europe, and the submission materials are usually in English, and in some cases, in French.

3.Asia:

Asia is an important destination for pharmaceutical companies going global. Among them, India and the Association of Southeast Asian Nations (ASEAN) show great potential. With the rapid economic development and the intensification of population aging, the demand for the pharmaceutical market continues to rise. However, there are significant cultural and policy differences in this region. The cultural backgrounds of various countries are diverse, and the medical systems and drug regulatory policies are different, which requires pharmaceutical companies to fully understand and adapt to these characteristics. At the same time, the demand for localization is high. Pharmaceutical companies must carry out localized R&D, production, and sales of drugs according to the local language, culture, and consumption habits, so as to improve the adaptability and competitiveness of products and achieve success in the Asian market.

(1)ASEAN: ASEAN covers ten Southeast Asian countries, such as Indonesia, Malaysia, Singapore, the Philippines, and Thailand. Each country will conduct approvals according to local conditions. Some countries require that the packaging labels and instructions of drugs be made in the local language, and the language types include Indonesian, Burmese, etc. Indonesia and Malaysia require that drugs meet halal certification.

(2)India: The listing of drugs in India is regulated by the Central Drugs Standard Control Organization (CDSCO). Listing requires applying for an import license and a drug registration certificate, and an Indian agency relationship is required. There are dozens or even hundreds of languages in India, and the application process is mainly in English, and some regions require the provision of Hindi content.

V. Challenges and Coping Strategies Faced by Pharmaceutical Companies Going Global

1. Regulatory and Supervision Challenges: The drug regulations and supervision requirements in different countries and regions vary greatly. Pharmaceutical companies need to spend time and energy understanding and complying with the local regulatory requirements to ensure the smooth progress of drug registration and listing. Coping strategies include establishing a professional regulatory team, cooperating with local regulatory consulting agencies, and conducting regulatory research and preparation in advance.

2. Cultural and Market Difference Challenges: The cultural backgrounds, medical habits, and market demands in different countries and regions are different. Pharmaceutical companies need to conduct comprehensive market research and analysis, understand the needs and preferences of local patients, and formulate corresponding marketing strategies. At the same time, strengthen cross-cultural communication and exchanges and improve international operation capabilities.

3. Competition Challenges: The overseas pharmaceutical market is highly competitive, and pharmaceutical companies need to face global competitors. To stand out, they need to continuously improve R&D capabilities and product quality, strengthen brand building and market promotion, and increase the added value and competitiveness of products.

4. Multilingual Environment: In the multilingual environment challenges faced by pharmaceutical companies going global, the complexity of languages cannot be underestimated. There are many countries and regions in Europe using multiple languages, such as English, French, German, Italian, etc. In the EU market, if the EMA centralized procedure (CP) is selected, pharmaceutical companies need to prepare documents in English and 24 official languages of EU local countries. The language requirements of each country in the ASEAN market are different, and English and corresponding local language translations need to be provided. The Indian market involves English and Hindi, etc. These language requirements bring many difficulties to the going-global of pharmaceutical companies. A lot of effort needs to be invested to ensure accurate language communication to meet the needs of different markets and avoid the impact of language barriers on the promotion and sales of drugs.

VI. About Glodom

Glodom Technology Co., Ltd., as a professional language technology solution provider, plays a crucial role in the process of pharmaceutical companies going global. The company's service areas cover multilingual translation, interpretation services, typesetting design, localization, multimedia services, technical services, etc. It involves industries such as software, ICT, games, finance, patents, and life sciences. It has more than 300 full-time employees and more than 5,000 native language translation experts in more than 40 countries around the world and can support more than 200 languages. It is familiar with the professional terms and industry knowledge in the pharmaceutical field and can accurately translate various drug-related documents.