In recent years, the demand for higher-quality pharmaceutical products has driven an increasing need for manufacturers to adhere to EU-GMP standards. While EU-GMP registration grants access to the European market and facilitates regulatory inspections, it demands strict compliance with EU regulations. Pharmaceutical manufacturers face a critical decision: to develop products in-house or to acquire existing EU-GMP registered dossiers from foreign markets.
1. Self-Development Process for EU-GMP Compliance
Manufacturers assume full responsibility from research to production, ensuring that products meet EU-GMP standards. The facility undergoes rigorous inspection and evaluation by the European Medicines Agency (EMA) before product authorization.
Subsequently, the manufacturer collaborates with a qualified marketing authorization holder (MAH) in the EU to register the product. These distributors need an import license from the manufacturer (Manufacturer Importer Authorisation).
Advantages:
- Full control of the process: Companies maintain complete control over the entire process from R&D to production and quality control, ensuring alignment with the company’s existing equipment and facilities.
- Easy product selection: Due to self-developed products, manufacturers can choose any product that fits their existing production line.
- Lower initial costs: Compared with purchasing documents from abroad, Research and development costs in countries like Vietnam are generally lower.
Disadvantages:
- Mandatory BE study: Most products when registered in Europe must be tested for BE (except for some cases that are exempted from studying). Currently, BE research facilities in Vietnam are not recognized by the EU, so it is necessary to find a testing facility approved by the EU (in the EU or some countries outside the EU such as India).
- Time-consuming: The entire process, including research, development, BE studies, and regulatory approval, can be lengthy, especially if products fail to meet specific quality criteria.
- High risk: There is a risk of failure during development if the product does not meet regulatory standards, stability or BE study.
2. Acquiring Existing EU-GMP Registered Dossiers
Acquiring an existing EU-GMP registered dossier involves a complex legal process. First, the product and target market need to be assessed and evaluated, then existing dossier must be carefully reviewed to ensure compliance with EU standards and compatible with the existing manufacturer’s facilities. The next step is to negotiate and agree on the acquisition of the dossier, including detailed legal and finacial due diligence, negotiating contract terms and signing the contract after reaching an agreement.
After the negotiation is completed, the transfer of the drug registration dossier will be carried out. This includes notifying the European Medicines Agency (EMA) of the change of ownership (MAH) and submitting an application for transfer with the necessary documents. The agency will review and make a decision on approval or rejection. After the change, the owner (MAH) will proceed to register the change or addition of the manufacturer to activate the inspection of the manufacturer in Vietnam.
Advantages:
- Time-saving: Formulas, procedures, and available documents should help shorten the time to complete sections of the application.
- Reduced risk: The product has been tested and meets foreign standards, reducing the risk of quality and effectiveness. No need to perform BE, just do dissolution equivalence.
Disadvantages:
- Limited product selection: Most of the products transferred under MA are old products that are no longer doing well in Europe. Some products that Vietnamese enterprises want to bid for in group 1 may not be able to find a transferor.
- Higher upfront costs: Acquisition costs is often higher than the cost of in-house developing.
- Limited options: To ensure successful technology transfer and suitability for registration, manufacturers must minimize changes in the registration dossier including suppliers of active ingredients, excipients, machinery and equipment, etc. This reduces flexibility and can prolong the preparation time for technology transfer activities. Some old dossiers will have low productivity and quite outdated equipment, so it is necessary to carefully evaluate before purchasing the dossier.
3. Making the Decision
In addition to the above options, there is also the option of purchasing expired CTD dossiers to quickly prepare the dossier. However, these dossiers often do not guarantee the ability to successfully transfer technology, so they need to be carefully evaluated before choosing. The decision to develop in-house or acquire an existing EU dossier depends on various factors, including:
- Financial resources
- R&D and manufacturing capabilities
- Target market and competitive landscape
- Project timeline
For companies with ample resources and a desire for complete control of a product with high commercial potential, in-house development may be the best option. However, for companies have insufficient technical team seeking a faster time-to-market, acquiring an existing dossier could be more suitable.
If you are still wondering which option is suitable, you can refer to EU GMP Consulting Service at SEN Pharm or contact SEN Pharma immediately (086 918 0917) for support.