to drug withdrawal and subsequently a loss of profit. The post­marketing requirements issued by regulators are also scant on details [72, 77]. Robust post-market evidence is essential in facilitating the successful implementation of accelerated approval programmes for the verification of the safety and ecacy of CTGTPs. However, post­market studies largely utilize methods similar to pre-market trials with minimal patient numbers and brief follow-up periods rather than using real-world scenarios for approved ATMPs in the EU [72, 78]. As such, regulations need to achieve the balance between flexi­bility in accommodating new knowledge and at the same time spe­cific in terms of setting out requirements in data submission.

As such, there is a need for the convergence of international regula­tions. Social science research has shown that emerging markets are stabilized when consumer confidence is boosted through creating standardized regulations [81, 82]. Currently, international harmo­nization initiatives, including the Gene and Cell Therapy Working Group of the International Pharmaceutical Regulators Form (IPRF) and ICH, are taking place, with the ICH being the primary organ­ization in generating shared technical guidelines to be utilized by dierent countries in the harmonization process. However, this requires a long time, which may not be rapid enough in dealing with the speed of innovation in the CTGTP area. As such, conver­gence may be a more desirable option, where regulatory require­ments align across countries by utilizing internationally recognized guidance documents [73]. This also provides time for manufacturers to understand any changes to regulations and to adapt manufactur­ing processes accordingly. By fostering close international cooper­ation, less advanced countries can also learn from more advanced countries without the need to abruptly adopt regulation standards, since they may not have the capacity to do so currently without being penalized unnecessarily.

to provide clarity to manufacturers. Many guidance documents are already available, such as the ‘PIC/S Annex 2A for Advanced Ther­apy Medicinal Products’ to guide manufacturers, as new scientific knowledge continues to emerge and evolve. With the help of inter­national organizations, the harmonization of regulations across the world is slowly beginning to materialize, providing guidance and greater clarity to countries that lag on regulations. International harmonization can also minimize the duplication of clinical trials and streamline the process of granting marketing authorizations for CTGTPs, thereby fostering innovation. There should also be greater and more eective communication between the regulator and dif­ferent stakeholders such as manufacturers, with feedback and some degree of flexibility incorporated into regulations.

The COVID-19 pandemic has accelerated digital transformation and exposed weak areas in pharmaceutical supply chains. At the same time, this has also presented opportunities for manufactur­ers and regulators to utilize technology to tackle the challenges of CTGTP manufacturing through new and innovative ways, ulti­mately improving the accessibility of these ground- breaking medi­cines to patients.